Invictus
SI. Core Fenestrated Closed Favored Angle Screw, 10.0mm X 130mm
14manufacturers in China registered for this device type
618catalogue numbers in this listing
9510(k) clearances naming this product code
32recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232275 |
| Record published | 2025-09-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 20 to 130 mm; outer diameter 4 to 12.5 mm; lumen/inner diameter 4.5 to 12.5 mm; width 10 to 62 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55575-065-085 | Length 85 mm | In distribution |
| 11511-085 | Lumen/Inner Diameter 8.5 mm | In distribution |
| 11004-100-050 | Outer Diameter 10.0 mm | In distribution |
| 55605-110-115 | Outer Diameter 11.0 mm | In distribution |
| 11002-090-070 | Outer Diameter 9.0 mm | In distribution |
| 11600-085 | Lumen/Inner Diameter 8.5 mm | In distribution |
| 11004-070-115 | Outer Diameter 7.0 mm | In distribution |
| 55675-115-095 | Outer Diameter 11.5 mm | In distribution |
| 55575-085-075 | Outer Diameter 8.5 mm | In distribution |
| 11301-28-38 | Width 28 mm | In distribution |
| 11004-040-030 | Outer Diameter 4.0 mm | In distribution |
| 55505-065-110 | Outer Diameter 6.5 mm | In distribution |
| 55505-095-035 | Outer Diameter 9.5 mm | In distribution |
| 11002-065-032 | Length 32.5 mm | In distribution |
| 11002-085-085 | Outer Diameter 8.5 mm | In distribution |
| 55505-095-045 | Length 45 mm | In distribution |
| 11004-105-075 | Length 75 mm | In distribution |
| 55505-085-085 | Length 85 mm | In distribution |
| 55505-120-070 | Outer Diameter 12 mm | In distribution |
| 55505-070-125 | Outer Diameter 7 mm | In distribution |
| 11004-065-070 | Outer Diameter 6.5 mm | In distribution |
| 55575-055-065 | Length 65 mm | In distribution |
| 11002-085-075 | Length 75 mm | In distribution |
| 11002-060-020 | Outer Diameter 6.0 mm | In distribution |
| 11004-100-075 | Outer Diameter 10.0 mm | In distribution |
| 11004-090-095 | Length 95 mm | In distribution |
| 11004-115-070 | Outer Diameter 11.5 mm | In distribution |
| 55675-055-060 | Outer Diameter 5.5 mm | In distribution |
| 55575-075-065 | Outer Diameter 7.5 mm | In distribution |
| 55575-100-090 | Length 90 mm | In distribution |
| 55675-095-075 | Outer Diameter 9.5 mm | In distribution |
| 55675-110-070 | Outer Diameter 11.0 mm | In distribution |
| 55575-080-115 | Length 115 mm | In distribution |
| 55575-125-060 | Outer Diameter 12.5 mm | In distribution |
| 11004-070-075 | Length 75 mm | In distribution |
| 55575-075-025 | Length 25 mm | In distribution |
| 55505-080-120 | Outer Diameter 8 mm | In distribution |
| 55575-115-055 | Length 55 mm | In distribution |
| 55505-075-035 | Outer Diameter 7.5 mm | In distribution |
| 55505-125-060 | Length 60 mm | In distribution |
| 11004-115-090 | Outer Diameter 11.5 mm | In distribution |
| 11002-080-105 | Outer Diameter 8.0 mm | In distribution |
| 11301-52-62 | Width 52 mm | In distribution |
| 55605-125-065 | Length 65 mm | In distribution |
| 55575-090-100 | Outer Diameter 9 mm | In distribution |
| 55675-090-030 | Length 30 mm | In distribution |
| 11502-105 | Lumen/Inner Diameter 10.5 mm | In distribution |
| 11004-110-035 | Outer Diameter 11.0 mm | In distribution |
| 55575-085-040 | Length 40 mm | In distribution |
| 55605-070-020 | Outer Diameter 7.0 mm | In distribution |
| 55505-060-050 | Outer Diameter 6 mm | In distribution |
| 55675-100-130 | Outer Diameter 10.0 mm | In distribution |
| 11002-070-045 | Length 45 mm | In distribution |
| 11004-065-032 | Outer Diameter 6.5 mm | In distribution |
| 55505-115-030 | Length 30 mm | In distribution |
| 11004-110-060 | Length 60 mm | In distribution |
| 11002-085-045 | Length 45 mm | In distribution |
| 11002-080-095 | Length 95 mm | In distribution |
| 11004-065-080 | Length 80 mm | In distribution |
| 11004-095-075 | Length 75 mm | In distribution |
| 55505-075-130 | Length 130 mm | In distribution |
| 11501-045 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 11514-125 | Lumen/Inner Diameter 12.5 mm | In distribution |
| 55505-100-055 | Outer Diameter 10 mm | In distribution |
| 11004-065-040 | Length 40 mm | In distribution |
| 11002-065-115 | Length 115 mm | In distribution |
| 11004-100-080 | Length 80 mm | In distribution |
| 11002-095-035 | Length 35 mm | In distribution |
| 55605-110-095 | Outer Diameter 11.0 mm | In distribution |
| 55675-095-065 | Outer Diameter 9.5 mm | In distribution |
| 55675-115-090 | Length 90 mm | In distribution |
| 55675-115-085 | Outer Diameter 11.5 mm | In distribution |
| 11004-080-080 | Length 80 mm | In distribution |
| 11002-090-085 | Outer Diameter 9.0 mm | In distribution |
| 55575-085-085 | Length 85 mm | In distribution |
| 55675-090-080 | Length 80 mm | In distribution |
| 11004-095-045 | Outer Diameter 9.5 mm | In distribution |
| 11002-080-085 | Outer Diameter 8.0 mm | In distribution |
| 11002-120-090 | Length 90 mm | In distribution |
| 55605-065-050 | Length 50 mm | In distribution |
| 11004-055-045 | Outer Diameter 5.5 mm | In distribution |
| 11004-090-080 | Outer Diameter 9.0 mm | In distribution |
| 55505-100-065 | Outer Diameter 10 mm | In distribution |
| 55605-105-130 | Outer Diameter 10.5 mm | In distribution |
| 11562-055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 55605-085-080 | Outer Diameter 8.5 mm | In distribution |
| 55675-100-075 | Outer Diameter 10.0 mm | In distribution |
| 55505-085-095 | Outer Diameter 8.5 mm | In distribution |
| 11002-100-085 | Outer Diameter 10.0 mm | In distribution |
| 11002-095-045 | Length 45 mm | In distribution |
| 55505-080-055 | Outer Diameter 8 mm | In distribution |
| 11002-125-070 | Length 70 mm | In distribution |
| 55575-115-120 | Outer Diameter 11.5 mm | In distribution |
| 55505-065-095 | Length 95 mm | In distribution |
| 55575-095-065 | Length 65 mm | In distribution |
| 11002-100-090 | Outer Diameter 10.0 mm | In distribution |
| 11004-090-085 | Length 85 mm | In distribution |
| 11002-095-055 | Outer Diameter 9.5 mm | In distribution |
| 55605-090-095 | Length 95 mm | In distribution |
| 55575-105-080 | Length 80 mm | In distribution |
| 55675-115-125 | Length 125 mm | In distribution |
| 55505-085-060 | Length 60 mm | In distribution |
| 55505-090-040 | Length 40 mm | In distribution |
| 55605-120-045 | Outer Diameter 12.0 mm | In distribution |
| 11004-080-110 | Length 110 mm | In distribution |
| 55505-070-030 | Outer Diameter 7 mm | In distribution |
| 55575-070-035 | Length 35 mm | In distribution |
| 11511-055 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 11004-060-025 | Length 25 mm | In distribution |
| 11004-100-115 | Length 115 mm | In distribution |
| 55675-125-035 | Outer Diameter 12.5 mm | In distribution |
| 11004-085-095 | Length 95 mm | In distribution |
| 55505-085-030 | Length 30 mm | In distribution |
| 11515-125 | Lumen/Inner Diameter 12.5 mm | In distribution |
| 55505-075-080 | Outer Diameter 7.5 mm | In distribution |
| 11611-085-R | Lumen/Inner Diameter 8.5 mm | In distribution |
| 11004-055-060 | Length 60 mm | In distribution |
| 55675-070-025 | Length 25 mm | In distribution |
| 55575-070-055 | Length 55 mm | In distribution |
| 55505-070-105 | Outer Diameter 7 mm | In distribution |
| 55675-100-100 | Length 100 mm | In distribution |
| 55505-065-115 | Length 115 mm | In distribution |
| 55605-105-115 | Outer Diameter 10.5 mm | In distribution |
| 55675-105-065 | Outer Diameter 10.5 mm | In distribution |
| 55505-105-105 | Length 105 mm | In distribution |
| 55605-095-060 | Outer Diameter 9.5 mm | In distribution |
| 55505-065-090 | Outer Diameter 6.5 mm | In distribution |
| 11002-100-095 | Length 95 mm | In distribution |
| 11004-065-035 | Length 35 mm | In distribution |
| 55675-125-030 | Length 30 mm | In distribution |
| 11002-105-110 | Outer Diameter 10.5 mm | In distribution |
| 55575-090-125 | Length 125 mm | In distribution |
| 11002-090-050 | Length 50 mm | In distribution |
| 55575-115-100 | Length 100 mm | In distribution |
| 55505-120-065 | Outer Diameter 12 mm | In distribution |
| 55675-055-045 | Length 45 mm | In distribution |
| 55505-065-035 | Outer Diameter 6.5 mm | In distribution |
| 55575-090-130 | Length 130 mm | In distribution |
| 55675-115-035 | Outer Diameter 11.5 mm | In distribution |
| 11004-065-115 | Length 115 mm | In distribution |
| 55575-105-065 | Outer Diameter 10.5 mm | In distribution |
| 55575-065-110 | Length 110 mm | In distribution |
| 55505-110-045 | Outer Diameter 11 mm | In distribution |
| 55605-095-075 | Outer Diameter 9.5 mm | In distribution |
| 55675-105-130 | Length 130 mm | In distribution |
| 11002-065-050 | Outer Diameter 6.5 mm | In distribution |
| 11002-050-050 | Outer Diameter 5.0 mm | In distribution |
| 55505-080-060 | Outer Diameter 8 mm | In distribution |
| 11004-055-027 | Length 27.5 mm | In distribution |
| 11004-065-055 | Length 55 mm | In distribution |
| 55605-060-040 | Outer Diameter 6.0 mm | In distribution |
| 55505-100-030 | Outer Diameter 10 mm | In distribution |
| 11004-060-055 | Length 55 mm | In distribution |
| 11002-110-085 | Length 85 mm | In distribution |
| 55505-120-050 | Outer Diameter 12 mm | In distribution |
| 11002-090-110 | Length 110 mm | In distribution |
| 11505-075 | Lumen/Inner Diameter 7.5 mm | In distribution |
| 55505-075-065 | Length 65 mm | In distribution |
| 11002-105-100 | Length 100 mm | In distribution |
| 55675-120-070 | Outer Diameter 12.0 mm | In distribution |
| 11002-085-060 | Outer Diameter 8.5 mm | In distribution |
| 55575-090-050 | Length 50 mm | In distribution |
| 11002-045-040 | Length 40 mm | In distribution |
| 55575-095-090 | Length 90 mm | In distribution |
| 11002-105-035 | Length 35 mm | In distribution |
| 11002-060-032 | Length 32.5 mm | In distribution |
| 55575-065-035 | Length 35 mm | In distribution |
| 11004-110-085 | Length 85 mm | In distribution |
| 55575-105-125 | Outer Diameter 10.5 mm | In distribution |
| 55505-090-100 | Length 100 mm | In distribution |
| 55575-090-070 | Length 70 mm | In distribution |
| 11002-110-130 | Outer Diameter 11.0 mm | In distribution |
| 55505-110-055 | Length 55 mm | In distribution |
| 11002-065-130 | Length 130 mm | In distribution |
| 11004-065-085 | Outer Diameter 6.5 mm | In distribution |
| 55505-125-075 | Length 75 mm | In distribution |
| 11513-085 | Lumen/Inner Diameter 8.5 mm | In distribution |
| 55505-065-065 | Outer Diameter 6.5 mm | In distribution |
| 55575-060-065 | Outer Diameter 6 mm | In distribution |
| 11301-20-30 | Width 20 mm | In distribution |
| 11004-105-100 | Length 100 mm | In distribution |
| 55575-065-080 | Outer Diameter 6.5 mm | In distribution |
| 11002-105-075 | Length 75 mm | In distribution |
| 11002-085-050 | Outer Diameter 8.5 mm | In distribution |
| 11004-045-045 | Outer Diameter 4.5 mm | In distribution |
| 55575-110-035 | Length 35 mm | In distribution |
| 11002-040-027 | Length 27.5 mm | In distribution |
| 11502-125 | Lumen/Inner Diameter 12.5 mm | In distribution |
| 55575-080-070 | Length 70 mm | In distribution |
| 55675-075-025 | Outer Diameter 7.5 mm | In distribution |
| 55505-085-075 | Length 75 mm | In distribution |
| 11004-115-060 | Outer Diameter 11.5 mm | In distribution |
| 55675-070-040 | Outer Diameter 7.0 mm | In distribution |
| 55505-115-060 | Outer Diameter 11.5 mm | In distribution |
| 11004-065-045 | Length 45 mm | In distribution |
| 55505-120-120 | Outer Diameter 12 mm | In distribution |
| 55575-065-030 | Length 30 mm | In distribution |
| 55505-065-030 | Outer Diameter 6.5 mm | In distribution |
| 11611-065-R | Lumen/Inner Diameter 6.5 mm | In distribution |
| 55675-075-050 | Outer Diameter 7.5 mm | In distribution |
| 55575-055-055 | Length 55 mm | In distribution |
| 55675-090-125 | Outer Diameter 9.0 mm | In distribution |
| 55575-085-070 | Length 70 mm | In distribution |
| 11510-075 | Lumen/Inner Diameter 7.5 mm | In distribution |
| 11004-085-080 | Outer Diameter 8.5 mm | In distribution |
| 11002-105-115 | Outer Diameter 10.5 mm | In distribution |
| 55605-125-055 | Length 55 mm | In distribution |
| 55605-125-050 | Length 50 mm | In distribution |
| 11004-125-095 | Length 95 mm | In distribution |
| 11002-075-120 | Length 120 mm | In distribution |
| 11002-045-020 | Length 20 mm | In distribution |
| 55505-065-085 | Outer Diameter 6.5 mm | In distribution |
| 11002-120-125 | Length 125 mm | In distribution |
| 55505-125-045 | Outer Diameter 12.5 mm | In distribution |
| 11515-115 | Lumen/Inner Diameter 11.5 mm | In distribution |
| 11002-125-095 | Outer Diameter 12.5 mm | In distribution |
| 55575-120-060 | Outer Diameter 12 mm | In distribution |
| 11004-065-027 | Length 27.5 mm | In distribution |
| 55675-110-095 | Length 95 mm | In distribution |
| 11002-125-050 | Outer Diameter 12.5 mm | In distribution |
| 55675-125-065 | Length 65 mm | In distribution |
| 11002-085-035 | Length 35 mm | In distribution |
| 11002-065-027 | Length 27.5 mm | In distribution |
| 55575-070-025 | Outer Diameter 7 mm | In distribution |
| 55505-120-055 | Outer Diameter 12 mm | In distribution |
| 55605-100-125 | Length 125 mm | In distribution |
| 55675-085-050 | Length 50 mm | In distribution |
| 55605-100-115 | Length 115 mm | In distribution |
| 11002-095-105 | Length 105 mm | In distribution |
| 55675-120-040 | Length 40 mm | In distribution |
| 11002-075-130 | Length 130 mm | In distribution |
| 55605-120-110 | Outer Diameter 12.0 mm | In distribution |
| 55605-115-030 | Length 30 mm | In distribution |
| 11004-065-030 | Length 30 mm | In distribution |
| 11002-100-065 | Length 65 mm | In distribution |
| 55605-100-055 | Outer Diameter 10.0 mm | In distribution |
| 11004-090-030 | Outer Diameter 9.0 mm | In distribution |
| 55675-070-045 | Outer Diameter 7.0 mm | In distribution |
| 11004-080-085 | Outer Diameter 8.0 mm | In distribution |
| 55675-065-055 | Outer Diameter 6.5 mm | In distribution |
| 55505-095-115 | Outer Diameter 9.5 mm | In distribution |
| 55605-055-065 | Length 65 mm | In distribution |
| 11004-075-055 | Outer Diameter 7.5 mm | In distribution |
| 11004-095-030 | Outer Diameter 9.5 mm | In distribution |
| 55675-120-080 | Length 80 mm | In distribution |
| 11004-060-020 | Outer Diameter 6.0 mm | In distribution |
| 11002-065-095 | Length 95 mm | In distribution |
| 55575-090-105 | Outer Diameter 9 mm | In distribution |
| 55675-110-100 | Length 100 mm | In distribution |
| 55505-090-090 | Outer Diameter 9 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251965 | 2025-08-28 |
| K233640 | 2024-02-22 |
| K230721 | 2023-05-09 |
| K213443 | 2021-12-15 |
| K200995 | 2020-05-21 |
| K182808 | 2018-11-09 |
| K102820 | 2010-11-05 |
| K101255 | 2010-07-21 |
| K070681 | 2007-05-04 |
Recalls
31 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 10 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 2 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 5 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 6 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 8 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 6 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 18 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 19 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 5 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 14 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 4 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 3 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 26 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 1 unit | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 7 units | 2022-11-17 |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 2022-11-17 | |
| 2021-04-26 | Class II | Under Investigation by firm | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. | 13 units | 2022-11-17 |
| 2015-04-10 | Class II | Employee error | During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recal | (244 units in US and 61 units OUS) | 2015-07-10 |
| 2012-05-29 | Class II | Device Design | On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate. | 38 | 2012-09-04 |
| 2009-08-25 | Not classified | Labeling mix-ups | The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical | 13 units | 2010-06-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.