Arsenal Deformity Spinal Fixation System
Arsenal Deformity is part of a posterior, non-cervical spinal fixation system. Rods, screws, bridges and connectors form a temporary internal construct that stabilizes the thoracic, lumbar…
Arsenal Deformity is part of a posterior, non-cervical spinal fixation system. Rods, screws, bridges and connectors form a temporary internal construct that stabilizes the thoracic, lumbar and sacral spine while bone graft heals.
Components are offered in different shapes and sizes for the treated anatomy and deformity. The system serves as an adjunct to fusion rather than replacing the fusion process.
Listed Item
30° Transverse Process Hook, Right, 7.5mm
Pediatric Configuration
The pediatric posterior pedicle-screw indication includes progressive spinal deformities such as idiopathic, neuromuscular and congenital scoliosis. Pediatric fixation is restricted to a posterior approach, with autograft and/or allograft used for fusion. Additional specified pediatric indications include spondylolisthesis, traumatic or tumor-related fracture and failed fusion.
15manufacturers in China registered for this device type
240catalogue 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) | K152968 |
| Record published | 2016-04-27 |
| Record revised | 2024-09-11 (version 7) |
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 | Outer diameter 3.5 to 10.5 mm; length 18 to 130 mm; angle 10 to 30 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48700-010-085-085 | Outer Diameter 8.5 mm | In distribution |
| 48800-045-035 | Length 35 mm | In distribution |
| 48700-020-090-105 | Outer Diameter 9 mm | In distribution |
| 48700-030-070-085 | Angle 30 ° | In distribution |
| 48700-025-075-020 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-080-040 | Outer Diameter 8 mm | In distribution |
| 48700-015-070-100 | Outer Diameter 7 mm | In distribution |
| 48700-030-095-065 | Angle 30 ° | In distribution |
| 48700-020-080-125 | Outer Diameter 8 mm | In distribution |
| 48600-037-075 | Angle 30 ° | In distribution |
| 48800-050-020 | Outer Diameter 5 mm | In distribution |
| 48700-010-070-025 | Outer Diameter 7 mm | In distribution |
| 48700-030-085-050 | Outer Diameter 8.5 mm | In distribution |
| 48700-020-070-050 | Outer Diameter 7 mm | In distribution |
| 48700-025-095-110 | Angle 25 ° | In distribution |
| 48700-020-070-045 | Outer Diameter 7 mm | In distribution |
| 48700-010-095-100 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-090-060 | Angle 30 ° | In distribution |
| 48700-025-070-035 | Length 35 mm | In distribution |
| 48700-020-105-080 | Outer Diameter 10.5 mm | In distribution |
| 48700-030-095-115 | Angle 30 ° | In distribution |
| 48700-030-075-125 | Angle 30 ° | In distribution |
| 48700-025-070-130 | Outer Diameter 7 mm | In distribution |
| 48700-030-105-060 | Angle 30 ° | In distribution |
| 48700-020-105-040 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-090-055 | Outer Diameter 9 mm | In distribution |
| 48700-020-070-040 | Outer Diameter 7 mm | In distribution |
| 48700-025-075-125 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-105-045 | Angle 25 ° | In distribution |
| 48700-025-090-120 | Outer Diameter 9 mm | In distribution |
| 48700-025-085-075 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-080-120 | Angle 30 ° | In distribution |
| 48700-025-095-115 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-095-045 | Length 45 mm | In distribution |
| 48700-010-095-055 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-105-080 | Length 80 mm | In distribution |
| 48700-030-090-115 | Angle 30 ° | In distribution |
| 48700-030-105-040 | Angle 30 ° | In distribution |
| 48700-025-090-105 | Length 105 mm | In distribution |
| 48700-030-090-125 | Outer Diameter 9 mm | In distribution |
| 48700-025-100-030 | Outer Diameter 10 mm | In distribution |
| 48700-025-090-040 | Outer Diameter 9 mm | In distribution |
| 48700-025-065-095 | Angle 25 ° | In distribution |
| 48800-070-030 | Outer Diameter 7 mm | In distribution |
| 48700-015-070-080 | Outer Diameter 7 mm | In distribution |
| 48700-010-070-040 | Outer Diameter 7 mm | In distribution |
| 48700-030-085-130 | Angle 30 ° | In distribution |
| 48700-015-070-045 | Outer Diameter 7 mm | In distribution |
| 48700-030-065-105 | Angle 30 ° | In distribution |
| 48700-025-075-025 | Length 25 mm | In distribution |
| 48700-020-080-080 | Length 80 mm | In distribution |
| 48700-025-065-120 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-095-110 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-095-130 | Length 130 mm | In distribution |
| 48700-030-085-105 | Angle 30 ° | In distribution |
| 48700-025-080-100 | Outer Diameter 8 mm | In distribution |
| 48700-030-075-115 | Angle 30 ° | In distribution |
| 48700-030-085-030 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-090-050 | Outer Diameter 9 mm | In distribution |
| 48700-015-095-050 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-090-115 | Outer Diameter 9 mm | In distribution |
| 48700-030-085-085 | Angle 30 ° | In distribution |
| 48700-030-105-125 | Angle 30 ° | In distribution |
| 48700-020-100-130 | Angle 20 ° | In distribution |
| 48700-030-095-125 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-090-130 | Length 130 mm | In distribution |
| 48700-025-075-120 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-065-105 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-105-060 | Outer Diameter 10.5 mm | In distribution |
| 48700-015-070-020 | Outer Diameter 7 mm | In distribution |
| 48700-015-065-085 | Length 85 mm | In distribution |
| 48700-030-080-110 | Outer Diameter 8 mm | In distribution |
| 48700-030-100-085 | Outer Diameter 10 mm | In distribution |
| 48700-010-100-130 | Outer Diameter 10 mm | In distribution |
| 48700-010-065-120 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-100-065 | Length 65 mm | In distribution |
| 48800-045-020 | Outer Diameter 4.5 mm | In distribution |
| 48001-35-18 | Length 18 mm | In distribution |
| 48700-015-100-100 | Outer Diameter 10 mm | In distribution |
| 48700-020-065-080 | Angle 20 ° | In distribution |
| 48700-025-100-055 | Outer Diameter 10 mm | In distribution |
| 48700-010-095-090 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-095-060 | Outer Diameter 9.5 mm | In distribution |
| 48700-020-100-075 | Outer Diameter 10 mm | In distribution |
| 48700-025-085-090 | Outer Diameter 8.5 mm | In distribution |
| 48700-020-095-065 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-075-030 | Angle 15 ° | In distribution |
| 48700-020-075-105 | Outer Diameter 7.5 mm | In distribution |
| 48700-020-095-130 | Length 130 mm | In distribution |
| 48027-55-060 | Length 60 mm | In distribution |
| 48800-040-035 | Length 35 mm | In distribution |
| 48700-020-065-030 | Outer Diameter 6.5 mm | In distribution |
| 48027-55-030 | Outer Diameter 5.5 mm | In distribution |
| 48700-010-085-100 | Outer Diameter 8.5 mm | In distribution |
| 48900-095-105 | Length 105 mm | In distribution |
| 48700-025-070-020 | Outer Diameter 7 mm | In distribution |
| 48700-010-105-130 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-065-040 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-090-030 | Length 30 mm | In distribution |
| 48001-35-22 | Length 22 mm | In distribution |
| 48700-025-085-070 | Outer Diameter 8.5 mm | In distribution |
| 48700-015-105-045 | Outer Diameter 10.5 mm | In distribution |
| 48700-025-080-110 | Outer Diameter 8 mm | In distribution |
| 48700-025-105-085 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-080-120 | Outer Diameter 8 mm | In distribution |
| 48700-020-065-100 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-105-085 | Outer Diameter 10.5 mm | In distribution |
| 48700-015-085-090 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-070-070 | Angle 30 ° | In distribution |
| 48700-030-090-060 | Outer Diameter 9 mm | In distribution |
| 48700-025-085-085 | Angle 25 ° | In distribution |
| 48700-010-100-100 | Outer Diameter 10 mm | In distribution |
| 48700-010-080-050 | Outer Diameter 8 mm | In distribution |
| 48700-020-105-075 | Outer Diameter 10.5 mm | In distribution |
| 48800-050-025 | Outer Diameter 5 mm | In distribution |
| 48700-015-095-055 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-090-120 | Angle 30 ° | In distribution |
| 48700-020-095-085 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-095-040 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-100-085 | Outer Diameter 10 mm | In distribution |
| 48700-015-065-040 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-085-035 | Outer Diameter 8.5 mm | In distribution |
| 48700-015-090-095 | Angle 15 ° | In distribution |
| 48700-025-105-065 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-105-035 | Outer Diameter 10.5 mm | In distribution |
| 48700-025-090-060 | Outer Diameter 9 mm | In distribution |
| 48700-020-095-080 | Outer Diameter 9.5 mm | In distribution |
| 48001-35-36 | Outer Diameter 3.5 mm | In distribution |
| 48700-025-065-115 | Outer Diameter 6.5 mm | In distribution |
| 48700-010-100-115 | Length 115 mm | In distribution |
| 48700-010-090-065 | Angle 10 ° | In distribution |
| 48700-015-080-115 | Outer Diameter 8 mm | In distribution |
| 48700-020-075-060 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-075-020 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-085-105 | Outer Diameter 8.5 mm | In distribution |
| 48700-025-100-045 | Angle 25 ° | In distribution |
| 48700-025-090-090 | Outer Diameter 9 mm | In distribution |
| 48700-010-085-095 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-100-075 | Angle 30 ° | In distribution |
| 48700-010-070-070 | Outer Diameter 7 mm | In distribution |
| 48700-020-105-070 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-070-130 | Length 130 mm | In distribution |
| 48001-045-26 | Outer Diameter 4.5 mm | In distribution |
| 48700-020-080-045 | Outer Diameter 8 mm | In distribution |
| 48700-015-095-035 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-070-115 | Outer Diameter 7 mm | In distribution |
| 48700-030-095-080 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-065-110 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-065-105 | Outer Diameter 6.5 mm | In distribution |
| 48001-045-24 | Length 24 mm | In distribution |
| 48001-045-22 | Length 22 mm | In distribution |
| 48700-010-065-130 | Angle 10 ° | In distribution |
| 48700-030-080-045 | Outer Diameter 8 mm | In distribution |
| 48700-020-090-065 | Angle 20 ° | In distribution |
| 48700-025-070-050 | Angle 25 ° | In distribution |
| 48700-015-075-080 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-095-105 | Outer Diameter 9.5 mm | In distribution |
| 48700-020-080-115 | Outer Diameter 8 mm | In distribution |
| 48700-025-095-105 | Outer Diameter 9.5 mm | In distribution |
| 48700-010-095-075 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-085-100 | Outer Diameter 8.5 mm | In distribution |
| 48800-045-045 | Length 45 mm | In distribution |
| 48700-015-085-060 | Outer Diameter 8.5 mm | In distribution |
| 48700-025-065-125 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-075-070 | Outer Diameter 7.5 mm | In distribution |
| 48027-55-050 | Length 50 mm | In distribution |
| 48700-015-080-130 | Outer Diameter 8 mm | In distribution |
| 48700-025-080-125 | Outer Diameter 8 mm | In distribution |
| 48700-015-075-035 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-070-120 | Length 120 mm | In distribution |
| 48700-010-080-030 | Outer Diameter 8 mm | In distribution |
| 48700-025-105-125 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-105-060 | Outer Diameter 10.5 mm | In distribution |
| 48700-015-100-090 | Angle 15 ° | In distribution |
| 48700-010-095-030 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-070-110 | Outer Diameter 7 mm | In distribution |
| 48700-015-095-065 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-080-115 | Outer Diameter 8 mm | In distribution |
| 48700-010-085-110 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-095-045 | Angle 30 ° | In distribution |
| 48700-015-085-080 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-080-050 | Angle 30 ° | In distribution |
| 48700-025-105-110 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-080-060 | Outer Diameter 8 mm | In distribution |
| 48700-025-105-130 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-105-120 | Outer Diameter 10.5 mm | In distribution |
| 48700-030-100-030 | Angle 30 ° | In distribution |
| 48700-015-105-070 | Outer Diameter 10.5 mm | In distribution |
| 48700-015-075-105 | Outer Diameter 7.5 mm | In distribution |
| 48700-020-100-110 | Outer Diameter 10 mm | In distribution |
| 48700-020-070-115 | Outer Diameter 7 mm | In distribution |
| 48700-020-070-030 | Outer Diameter 7 mm | In distribution |
| 48700-020-085-125 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-100-055 | Length 55 mm | In distribution |
| 48700-025-100-060 | Outer Diameter 10 mm | In distribution |
| 48700-015-090-070 | Outer Diameter 9 mm | In distribution |
| 48800-055-060 | Outer Diameter 5.5 mm | In distribution |
| 48700-010-070-110 | Outer Diameter 7 mm | In distribution |
| 48700-025-065-065 | Outer Diameter 6.5 mm | In distribution |
| 48700-010-095-065 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-090-085 | Angle 30 ° | In distribution |
| 48700-030-070-040 | Angle 30 ° | In distribution |
| 48700-010-085-070 | Angle 10 ° | In distribution |
| 48700-025-105-055 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-080-075 | Outer Diameter 8 mm | In distribution |
| 48700-025-065-090 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-065-095 | Angle 30 ° | In distribution |
| 48700-030-075-045 | Angle 30 ° | In distribution |
| 48700-020-085-055 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-105-045 | Angle 30 ° | In distribution |
| 48700-010-065-085 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-085-120 | Angle 30 ° | In distribution |
| 48700-025-080-070 | Outer Diameter 8 mm | In distribution |
| 48700-020-065-115 | Outer Diameter 6.5 mm | In distribution |
| 48700-010-070-045 | Outer Diameter 7 mm | In distribution |
| 48700-025-100-120 | Outer Diameter 10 mm | In distribution |
| 48700-025-085-065 | Outer Diameter 8.5 mm | In distribution |
| 48700-010-065-115 | Outer Diameter 6.5 mm | In distribution |
| 48800-060-050 | Outer Diameter 6 mm | In distribution |
| 48700-020-080-110 | Outer Diameter 8 mm | In distribution |
| 48700-020-100-035 | Outer Diameter 10 mm | In distribution |
| 48700-010-100-080 | Length 80 mm | In distribution |
| 48700-020-085-060 | Length 60 mm | In distribution |
| 48700-030-075-050 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-070-095 | Length 95 mm | In distribution |
| 48700-010-105-055 | Outer Diameter 10.5 mm | In distribution |
| 48001-040-18 | Outer Diameter 4 mm | In distribution |
| 48700-030-090-110 | Angle 30 ° | In distribution |
| 48700-020-100-060 | Outer Diameter 10 mm | In distribution |
| 48700-020-065-050 | Outer Diameter 6.5 mm | In distribution |
| 48001-35-33 | Outer Diameter 3.5 mm | In distribution |
| 48700-025-080-090 | Outer Diameter 8 mm | In distribution |
| 48700-025-070-040 | Outer Diameter 7 mm | In distribution |
| 48700-010-065-095 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-095-070 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-065-130 | Length 130 mm | In distribution |
| 48700-030-095-055 | Angle 30 ° | In distribution |
| 48700-020-095-055 | Outer Diameter 9.5 mm | In distribution |
| 48700-020-075-125 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-075-065 | Outer Diameter 7.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| 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 |
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.