Invictus
Fenestrated Cannulated Cortical-Cancellous Extended Tab Polyaxial Reduction Screw Ø10.5mm X 115mm
15manufacturers in China registered for this device type
4,722catalogue numbers in this listing
20510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232275 |
| Record published | 2024-10-25 |
| Record revised | 2025-07-14 (version 5) |
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, manufacturing date |
| Sizes | Length 5 to 600 mm; outer diameter 4 to 12.5 mm; lumen/inner diameter 4.5 to 12.5 mm; height 4 to 12.5 mm; width 10 to 600 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55305-065-055 | Length 55 mm | In distribution |
| 55223-050-030 | Outer Diameter 5 mm | In distribution |
| 15074-095-120 | Length 120 mm | In distribution |
| 55105-125-070 | Length 70 mm | In distribution |
| 15041-105-090 | Outer Diameter 10.5 mm | In distribution |
| 15210-55-095 | Outer Diameter 5.5 mm | In distribution |
| 15004-125-060 | Length 60 mm | In distribution |
| 55205-085-095 | Outer Diameter 8.5 mm | In distribution |
| 15511-085 | Height 8.5 mm | In distribution |
| 15003-090-075 | Length 75 mm | In distribution |
| 15003-110-100 | Outer Diameter 11 mm | In distribution |
| 55505-095-085 | Length 85 mm | In distribution |
| 15704-100-080 | Length 80 mm | In distribution |
| 15704-120-105 | Outer Diameter 12 mm | In distribution |
| 55203-100-060 | Length 60 mm | In distribution |
| 15701-125-050 | Outer Diameter 12.5 mm | In distribution |
| 15013-055-040 | Length 40 mm | In distribution |
| 15263-55-500 | Outer Diameter 5.5 mm | In distribution |
| 15701-125-100 | Outer Diameter 12.5 mm | In distribution |
| 55405-075-030 | Outer Diameter 7.5 mm | In distribution |
| 55203-125-035 | Outer Diameter 12.5 mm | In distribution |
| 55605-085-055 | Outer Diameter 8.5 mm | In distribution |
| 55223-085-060 | Outer Diameter 8.5 mm | In distribution |
| 15704-125-055 | Outer Diameter 12.5 mm | In distribution |
| 55205-075-035 | Outer Diameter 7.5 mm | In distribution |
| 11004-070-090 | Outer Diameter 7.0 mm | In distribution |
| 15274-55-60-300 | In distribution | |
| 55225-050-040 | Outer Diameter 5 mm | In distribution |
| 55675-055-050 | Outer Diameter 5.5 mm | In distribution |
| 15230-55-120 | Outer Diameter 5.5 mm | In distribution |
| 55203-070-055 | Outer Diameter 7 mm | In distribution |
| 55505-100-035 | Length 35 mm | In distribution |
| 55405-125-060 | Outer Diameter 12.5 mm | In distribution |
| 15054-120-090 | Outer Diameter 12 mm | In distribution |
| 15704-120-130 | Outer Diameter 12 mm | In distribution |
| 15270-55-60-500 | In distribution | |
| 15034-040-020 | Length 20 mm | In distribution |
| 55303-105-070 | Length 70 mm | In distribution |
| 55675-125-125 | Outer Diameter 12.5 mm | In distribution |
| 55475-100-080 | Length 80 mm | In distribution |
| 15055-055-025 | Length 25 mm | In distribution |
| 55475-115-085 | Outer Diameter 11.5 mm | In distribution |
| 15005-085-055 | Length 55 mm | In distribution |
| 55105-065-020 | Outer Diameter 6.5 mm | In distribution |
| 55005-110-055 | Length 55 mm | In distribution |
| 15011-115-115 | Outer Diameter 11.5 mm | In distribution |
| 15021-075-060 | Outer Diameter 7.5 mm | In distribution |
| 55075-075-095 | Length 95 mm | In distribution |
| 15011-080-100 | Outer Diameter 8 mm | In distribution |
| 55675-115-110 | Outer Diameter 11.5 mm | In distribution |
| 15210-60-110 | Length 110 mm | In distribution |
| 15312-60 | In distribution | |
| 15054-120-115 | Length 115 mm | In distribution |
| 15054-080-085 | Length 85 mm | In distribution |
| 15041-085-090 | Outer Diameter 8.5 mm | In distribution |
| 15701-055-065 | Length 65 mm | In distribution |
| 55405-075-020 | Outer Diameter 7.5 mm | In distribution |
| 16702 | In distribution | |
| 15013-055-050 | Length 50 mm | In distribution |
| 55505-085-105 | Length 105 mm | In distribution |
| 55475-090-040 | Length 40 mm | In distribution |
| 55605-125-130 | Length 130 mm | In distribution |
| 15031-125-080 | Outer Diameter 12.5 mm | In distribution |
| 15226-60-055 | Outer Diameter 6 mm | In distribution |
| 15041-070-105 | Outer Diameter 7 mm | In distribution |
| 15003-065-105 | Length 105 mm | In distribution |
| 55223-075-050 | Outer Diameter 7.5 mm | In distribution |
| 11002-075-025 | Outer Diameter 7.5 mm | In distribution |
| 11002-095-050 | Outer Diameter 9.5 mm | In distribution |
| 15714-110-115 | Outer Diameter 11 mm | In distribution |
| 55675-090-105 | Outer Diameter 9.0 mm | In distribution |
| 15034-040-030 | Height 4 mm | In distribution |
| 11004-055-030 | Outer Diameter 5.5 mm | In distribution |
| 15295-55-050 | Outer Diameter 5.5 mm | In distribution |
| 55075-070-110 | Length 110 mm | In distribution |
| 15021-115-110 | Length 110 mm | In distribution |
| 15220-60-160 | Length 160 mm | In distribution |
| 15003-060-025 | Outer Diameter 6 mm | In distribution |
| 15222-60-600 | Length 600 mm | In distribution |
| 15701-115-070 | Length 70 mm | In distribution |
| 15003-095-105 | Outer Diameter 9.5 mm | In distribution |
| 11002-115-045 | Outer Diameter 11.5 mm | In distribution |
| 15003-065-120 | Outer Diameter 6.5 mm | In distribution |
| 55203-120-090 | Length 90 mm | In distribution |
| 15055-060-035 | Outer Diameter 6 mm | In distribution |
| 15011-055-040 | Outer Diameter 5.5 mm | In distribution |
| 15011-100-110 | Length 110 mm | In distribution |
| 55605-100-070 | Outer Diameter 10.0 mm | In distribution |
| 15054-080-040 | Length 40 mm | In distribution |
| 55213-060-055 | Outer Diameter 6 mm | In distribution |
| 15703-075-095 | Outer Diameter 7.5 mm | In distribution |
| 55305-085-060 | Outer Diameter 8.5 mm | In distribution |
| 15023-110-030 | Outer Diameter 11 mm | In distribution |
| 15001-085-115 | Length 115 mm | In distribution |
| 15001-110-035 | Length 35 mm | In distribution |
| 55305-105-030 | Outer Diameter 10.5 mm | In distribution |
| 55475-075-045 | Length 45 mm | In distribution |
| 55075-065-065 | Length 65 mm | In distribution |
| 55203-090-085 | Outer Diameter 9 mm | In distribution |
| 55475-120-055 | Length 55 mm | In distribution |
| 15055-060-030 | Outer Diameter 6 mm | In distribution |
| 55675-075-020 | Length 20 mm | In distribution |
| 55675-100-070 | Outer Diameter 10.0 mm | In distribution |
| 15705-115-070 | Outer Diameter 11.5 mm | In distribution |
| 15704-080-100 | Length 100 mm | In distribution |
| 15031-075-040 | Length 40 mm | In distribution |
| 15055-100-110 | Outer Diameter 10 mm | In distribution |
| 15011-095-065 | Outer Diameter 9.5 mm | In distribution |
| 55605-090-065 | Outer Diameter 9.0 mm | In distribution |
| 15262-60-500 | Length 500 mm | In distribution |
| 15003-060-050 | Length 50 mm | In distribution |
| 15703-120-065 | Outer Diameter 12 mm | In distribution |
| 15054-105-075 | Outer Diameter 10.5 mm | In distribution |
| 15054-060-045 | Outer Diameter 6 mm | In distribution |
| 55475-115-090 | Outer Diameter 11.5 mm | In distribution |
| 15222-55-500 | Length 500 mm | In distribution |
| 15023-050-045 | Outer Diameter 5 mm | In distribution |
| 55203-120-045 | Outer Diameter 12 mm | In distribution |
| 55605-085-045 | Outer Diameter 8.5 mm | In distribution |
| 15054-120-100 | Length 100 mm | In distribution |
| 15044-050-055 | Outer Diameter 5 mm | In distribution |
| 15701-050-030 | Outer Diameter 5 mm | In distribution |
| 15055-120-030 | Outer Diameter 12 mm | In distribution |
| 15044-075-050 | Length 50 mm | In distribution |
| 15021-085-040 | Outer Diameter 8.5 mm | In distribution |
| 15226-55-030 | Outer Diameter 5.5 mm | In distribution |
| 15280-60-055 | Outer Diameter 6 mm | In distribution |
| 55305-055-035 | Length 35 mm | In distribution |
| 11002-110-065 | Length 65 mm | In distribution |
| 15025-105-060 | Length 60 mm | In distribution |
| 15222-60-160 | Length 160 mm | In distribution |
| 55105-110-120 | Outer Diameter 11 mm | In distribution |
| 11505-065 | Lumen/Inner Diameter 6.5 mm | In distribution |
| 55105-095-040 | Length 40 mm | In distribution |
| 55575-085-105 | Outer Diameter 8.5 mm | In distribution |
| 15703-060-065 | Outer Diameter 6 mm | In distribution |
| 55005-115-080 | Outer Diameter 11.5 mm | In distribution |
| 15021-065-040 | Length 40 mm | In distribution |
| 55213-085-055 | Length 55 mm | In distribution |
| 15001-120-125 | Length 125 mm | In distribution |
| 15703-080-030 | Length 30 mm | In distribution |
| 55575-105-095 | Length 95 mm | In distribution |
| 15054-125-120 | Length 120 mm | In distribution |
| 15262-60-400 | Length 400 mm | In distribution |
| 15701-100-095 | Length 95 mm | In distribution |
| 55223-105-115 | Outer Diameter 10.5 mm | In distribution |
| 15023-065-125 | Length 125 mm | In distribution |
| 15222-60-300 | Length 300 mm | In distribution |
| 15705-075-095 | Outer Diameter 7.5 mm | In distribution |
| 15023-100-115 | Outer Diameter 10 mm | In distribution |
| 55075-065-075 | Outer Diameter 6.5 mm | In distribution |
| 55203-055-035 | Length 35 mm | In distribution |
| 15705-060-025 | Outer Diameter 6 mm | In distribution |
| 15021-065-075 | Outer Diameter 6.5 mm | In distribution |
| 55605-075-045 | Outer Diameter 7.5 mm | In distribution |
| 15031-105-085 | Length 85 mm | In distribution |
| 15021-090-075 | Outer Diameter 9 mm | In distribution |
| 11004-085-075 | Length 75 mm | In distribution |
| 15013-065-125 | Outer Diameter 6.5 mm | In distribution |
| 15041-115-045 | Length 45 mm | In distribution |
| 55075-065-050 | Outer Diameter 6.5 mm | In distribution |
| 15023-115-095 | Length 95 mm | In distribution |
| 15021-105-105 | Outer Diameter 10.5 mm | In distribution |
| 15232-55-075 | Outer Diameter 5.5 mm | In distribution |
| 15409-110 | Length 110 mm | In distribution |
| 55575-085-130 | Outer Diameter 8.5 mm | In distribution |
| 15420-15 | In distribution | |
| 55205-055-030 | Length 30 mm | In distribution |
| 55305-070-060 | Outer Diameter 7.0 mm | In distribution |
| 15013-105-110 | Length 110 mm | In distribution |
| 15701-070-055 | Outer Diameter 7 mm | In distribution |
| 15225-55-120 | Outer Diameter 5.5 mm | In distribution |
| 15013-120-110 | Outer Diameter 12 mm | In distribution |
| 15013-090-080 | Outer Diameter 9 mm | In distribution |
| 15013-120-090 | Length 90 mm | In distribution |
| 15041-080-075 | Outer Diameter 8 mm | In distribution |
| 15263-60-500 | Length 500 mm | In distribution |
| 15054-110-100 | Outer Diameter 11 mm | In distribution |
| 15703-080-055 | Length 55 mm | In distribution |
| 55225-075-075 | Length 75 mm | In distribution |
| 55303-095-085 | Outer Diameter 9.5 mm | In distribution |
| 15011-110-110 | Outer Diameter 11 mm | In distribution |
| 11002-105-045 | Length 45 mm | In distribution |
| 15714-120-110 | Length 110 mm | In distribution |
| 15011-080-040 | Outer Diameter 8 mm | In distribution |
| 15703-080-035 | Length 35 mm | In distribution |
| 55223-125-045 | Length 45 mm | In distribution |
| 15531-105 | Height 10.5 mm | In distribution |
| 55213-095-100 | Outer Diameter 9.5 mm | In distribution |
| 15034-045-040 | Outer Diameter 4.5 mm | In distribution |
| 15023-105-035 | Outer Diameter 10.5 mm | In distribution |
| 15703-065-035 | Outer Diameter 6.5 mm | In distribution |
| 55215-055-060 | Length 60 mm | In distribution |
| 15705-120-070 | Length 70 mm | In distribution |
| 11200-50-500 | Length 500 mm | In distribution |
| 55305-095-060 | Length 60 mm | In distribution |
| 55215-085-090 | Length 90 mm | In distribution |
| 15025-095-050 | Length 50 mm | In distribution |
| 15021-070-065 | Outer Diameter 7 mm | In distribution |
| 15004-065-065 | Outer Diameter 6.5 mm | In distribution |
| 55205-105-120 | Outer Diameter 10.5 mm | In distribution |
| 15021-090-130 | Outer Diameter 9 mm | In distribution |
| 55475-120-040 | Length 40 mm | In distribution |
| 15704-105-040 | Length 40 mm | In distribution |
| 55105-115-045 | Outer Diameter 11.5 mm | In distribution |
| 55005-080-110 | Outer Diameter 8 mm | In distribution |
| 15704-065-045 | Length 45 mm | In distribution |
| 55005-090-075 | Length 75 mm | In distribution |
| 15021-075-125 | Length 125 mm | In distribution |
| 55223-065-035 | Length 35 mm | In distribution |
| 15005-085-050 | Outer Diameter 8.5 mm | In distribution |
| 15714-085-100 | Outer Diameter 8.5 mm | In distribution |
| 55605-110-060 | Length 60 mm | In distribution |
| 11002-110-040 | Length 40 mm | In distribution |
| 15705-055-055 | Outer Diameter 5.5 mm | In distribution |
| 11002-095-065 | Length 65 mm | In distribution |
| 55605-090-055 | Outer Diameter 9.0 mm | In distribution |
| 55405-085-045 | Outer Diameter 8.5 mm | In distribution |
| 55405-125-080 | Outer Diameter 12.5 mm | In distribution |
| 15714-065-030 | Length 30 mm | In distribution |
| 55605-055-025 | Length 25 mm | In distribution |
| 55005-125-095 | Outer Diameter 12.5 mm | In distribution |
| 15025-065-020 | Length 20 mm | In distribution |
| 15704-040-035 | Length 35 mm | In distribution |
| 15704-095-035 | Outer Diameter 9.5 mm | In distribution |
| 15021-085-110 | Outer Diameter 8.5 mm | In distribution |
| 15703-125-030 | Length 30 mm | In distribution |
| 15025-065-115 | Outer Diameter 6.5 mm | In distribution |
| 15001-125-100 | Outer Diameter 12.5 mm | In distribution |
| 15013-060-065 | Outer Diameter 6 mm | In distribution |
| 55575-110-060 | Outer Diameter 11 mm | In distribution |
| 15034-065-050 | Outer Diameter 6.5 mm | In distribution |
| 15041-110-035 | Length 35 mm | In distribution |
| 11300-44-54 | Width 44 mm | In distribution |
| 11002-120-070 | Length 70 mm | In distribution |
| 15701-105-120 | Outer Diameter 10.5 mm | In distribution |
| 15011-040-060 | Outer Diameter 4 mm | In distribution |
| 15011-095-095 | Outer Diameter 9.5 mm | In distribution |
| 15041-075-095 | Outer Diameter 7.5 mm | In distribution |
| 15055-090-100 | Length 100 mm | In distribution |
| 15055-110-125 | Outer Diameter 11 mm | In distribution |
| 55605-085-060 | Outer Diameter 8.5 mm | In distribution |
| 15011-085-100 | Outer Diameter 8.5 mm | In distribution |
| 15041-100-055 | Length 55 mm | In distribution |
| 15704-110-115 | Outer Diameter 11 mm | In distribution |
| 15003-070-080 | Length 80 mm | In distribution |
| 55105-115-085 | Outer Diameter 11.5 mm | In distribution |
| 15041-095-105 | Length 105 mm | In distribution |
| 15044-055-025 | Outer Diameter 5.5 mm | In distribution |
| 15013-100-055 | Outer Diameter 10 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
| Vital™ | Biomet Spine | 2,355 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261284 | 2026-07-14 |
| K241519 | 2024-06-21 |
| K232275 | 2023-09-27 |
| K214006 | 2022-04-04 |
| K213460 | 2021-12-10 |
| K203056 | 2020-11-23 |
| K202327 | 2020-10-15 |
| K192938 | 2019-12-12 |
| K181980 | 2018-09-25 |
| K181677 | 2018-08-09 |
| K173522 | 2017-11-30 |
| K161363 | 2016-06-10 |
| K152968 | 2015-12-30 |
| K143149 | 2015-01-05 |
| K133221 | 2014-03-13 |
| K131119 | 2013-05-21 |
| K123623 | 2013-02-14 |
| K111634 | 2012-01-25 |
| K111076 | 2011-07-12 |
| K071380 | 2007-08-20 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2017-05-05 | Class II | Under Investigation by firm | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. | 16,959 units | 2017-06-06 |
| 2016-10-05 | Class II | Under Investigation by firm | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. | 16,972 units | 2017-02-17 |
| 2014-06-26 | Class II | Unknown/Undetermined by firm | Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use. | 14 units total (12 units in US) | 2014-09-03 |
| 2013-06-28 | Class II | Equipment maintenance | The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mat | 333 screws | 2014-10-09 |
| 2013-05-06 | Class II | Device Design | Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia” Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this cond | 1,814 | 2014-09-25 |
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.