MaxAn Anterior Cervical Plate System
4.5 X20MM Blunt Variable Screw
14manufacturers in China registered for this device type
370catalogue numbers in this listing
3recalls 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 | Highridge Medical, LLC, 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, Manufacturer |
| Record published | 2025-11-12 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-521650B | Device Size Text, specify—4.5 X20MM BLUNT VARIABLE SCREW | In distribution |
| 14-522390 | In distribution | |
| 14-521516E | In distribution | |
| 14-521650E | In distribution | |
| 14-521624E | In distribution | |
| 14-522155 | Device Size Text, specify—5-Level 75 mm Fixed Plate MAXAN | In distribution |
| 14-521511 | Device Size Text, specify—4.0MM X 11MM FIXED SCREW | In distribution |
| 14-521638B | Device Size Text, specify—4.5 X 8MM BLUNT VARIABLE SCREW | In distribution |
| 14-521654BE | Device Size Text, specify—4.5 X24MM BLUNT VARIABLE SCREW | In distribution |
| 14-521517 | Device Size Text, specify—4.0MM X 17MM FIXED SCREW | In distribution |
| 14-522248 | Device Size Text, specify—2 LEVEL 48MM FIXED PLATE | In distribution |
| 14-521552BE | Device Size Text, specify—4.5MM X 22MM BLUNT FIXED SCREW | In distribution |
| 14-521648E | In distribution | |
| 14-522134E | In distribution | |
| 14-521546E | In distribution | |
| 14-522113 | Device Size Text, specify—1 LEVEL 13MM FIXED PLATE | In distribution |
| 14-522266E | Device Size Text, specify—2 LEVEL 66MM FIXED PLATE | In distribution |
| 14-522357 | In distribution | |
| 14-521553 | Device Size Text, specify—4.5MM X 23MM FIXED SCREW | In distribution |
| 14-522244E | Device Size Text, specify—2 LEVEL 44MM FIXED PLATE | In distribution |
| 14-522492 | In distribution | |
| 14-522112 | Device Size Text, specify—1 LEVEL 12MM FIXED PLATE | In distribution |
| 14-521519 | Device Size Text, specify—4.0MM X 19MM FIXED SCREW | In distribution |
| 14-522254E | Device Size Text, specify—2 LEVEL 54MM FIXED PLATE | In distribution |
| 14-521554B | Device Size Text, specify—4.5 X 24MM BLUNT FIXED SCREW | In distribution |
| 14-522224E | In distribution | |
| 14-522128 | Device Size Text, specify—1 LEVEL 28MM FIXED PLATE | In distribution |
| 14-522372E | Device Size Text, specify—3 LEVEL 72MM FIXED PLATE | In distribution |
| 14-521542 | Device Size Text, specify—4.5MM X 12MM FIXED SCREW | In distribution |
| 14-522468E | Device Size Text, specify—4 LEVEL 68MM FIXED PLATE | In distribution |
| 14-521618 | Device Size Text, specify—4.0MM X 18MM VARIABLE SCREW | In distribution |
| 14-521644B | Device Size Text, specify—4.5 X14MM BLUNT VARIABLE SCREW | In distribution |
| 14-521642B | Device Size Text, specify—4.5 X12MM BLUNT VARIABLE SCREW | In distribution |
| 14-522378 | In distribution | |
| 14-522242 | Device Size Text, specify—2 LEVEL 42MM FIXED PLATE | In distribution |
| 14-521609 | Device Size Text, specify—4.0MM X 9MM VARIABLE SCREW | In distribution |
| 14-522354 | In distribution | |
| 14-522339E | Device Size Text, specify—3 LEVEL 39MM FIXED PLATE | In distribution |
| 14-522236 | Device Size Text, specify—2 LEVEL 36MM FIXED PLATE | In distribution |
| 14-521654E | In distribution | |
| 14-521618E | In distribution | |
| 14-522260E | Device Size Text, specify—2 LEVEL 60MM FIXED PLATE | In distribution |
| 14-521556BE | Device Size Text, specify—4.5MM X 26MM BLUNT FIXED SCREW | In distribution |
| 14-521642E | In distribution | |
| 14-522116 | Device Size Text, specify—1 LEVEL 16MM FIXED PLATE | In distribution |
| 14-521648 | Device Size Text, specify—4.5MM X 18MM VARIABLE SCREW | In distribution |
| 14-522136 | Device Size Text, specify—1 LEVEL 36MM FIXED PLATE | In distribution |
| 14-521612E | In distribution | |
| 14-521516B | Device Size Text, specify—4.0 X 16MM BLUNT FIXED SCREW | In distribution |
| 14-521618B | Device Size Text, specify—4.0 X18MM BLUNT VARIABLE SCREW | In distribution |
| 14-522109 | Device Size Text, specify—1 LEVEL 9MM FIXED PLATE | In distribution |
| 14-522145 | Device Size Text, specify—5-Level 65 mm Fixed Plate MAXAN | In distribution |
| 14-522452E | Device Size Text, specify—4 Level 52 mm Fixed Plate | In distribution |
| 14-521626BE | Device Size Text, specify—4.0 X26MM BLUNT VARIABLE SCREW | In distribution |
| 14-522136E | In distribution | |
| 14-521522BE | Device Size Text, specify—4.0MM X 22MM BLUNT FIXED SCREW | In distribution |
| 14-521622E | In distribution | |
| 14-521617 | Device Size Text, specify—4.0MM X 17MM VARIABLE SCREW | In distribution |
| 14-522266 | Device Size Text, specify—2 LEVEL 66MM FIXED PLATE | In distribution |
| 14-521542B | Device Size Text, specify—4.5 X 12MM BLUNT FIXED SCREW | In distribution |
| 14-521524B | Device Size Text, specify—4.0 X 24MM BLUNT FIXED SCREW | In distribution |
| 14-522128E | In distribution | |
| 14-522222E | In distribution | |
| 14-522190 | Device Size Text, specify—5-Level 110 mm Fixed Plate MAXAN | In distribution |
| 14-521539 | Device Size Text, specify—4.5MM X 9MM FIXED SCREW | In distribution |
| 14-522387E | Device Size Text, specify—3 LEVEL 87MM FIXED PLATE | In distribution |
| 14-521510B | Device Size Text, specify—4.0 X 10MM BLUNT FIXED SCREW | In distribution |
| 14-521526BE | Device Size Text, specify—4.0MM X 26MM BLUNT FIXED SCREW | In distribution |
| 14-522500E | Device Size Text, specify—4 LEVEL 100MM FIXED PLATE | In distribution |
| 14-522224 | Device Size Text, specify—2 LEVEL 24MM FIXED PLATE | In distribution |
| 14-521612 | Device Size Text, specify—4.0MM X 12MM VARIABLE SCREW | In distribution |
| 14-521510E | In distribution | |
| 14-521624 | Device Size Text, specify—4.0MM X 24MM VARIABLE SCREW | In distribution |
| 14-522468 | In distribution | |
| 14-521611 | Device Size Text, specify—4.0MM X 11MM VARIABLE SCREW | In distribution |
| 14-521649 | Device Size Text, specify—4.5MM X 19MM VARIABLE SCREW | In distribution |
| 14-522222 | Device Size Text, specify—2 LEVEL 22MM FIXED PLATE | In distribution |
| 14-521651 | Device Size Text, specify—4.5MM X 21MM VARIABLE SCREW | In distribution |
| 14-522456 | In distribution | |
| 14-521520B | Device Size Text, specify—4.0 X 20MM BLUNT FIXED SCREW | In distribution |
| 14-522262 | Device Size Text, specify—2 LEVEL 62MM FIXED PLATE | In distribution |
| 14-521518BE | Device Size Text, specify—4.0MM X 18MM BLUNT FIXED SCREW | In distribution |
| 14-522228 | Device Size Text, specify—2 LEVEL 28MM FIXED PLATE | In distribution |
| 14-522333 | Device Size Text, specify—3 LEVEL 33MM FIXED PLATE | In distribution |
| 14-521526E | In distribution | |
| 14-521653 | Device Size Text, specify—4.5MM X 23MM VARIABLE SCREW | In distribution |
| 14-521543 | Device Size Text, specify—4.5MM X 13MM FIXED SCREW | In distribution |
| 14-521641 | Device Size Text, specify—4.5MM X 11MM VARIABLE SCREW | In distribution |
| 14-522268 | Device Size Text, specify—2 LEVEL 68MM FIXED PLATE | In distribution |
| 14-522111E | In distribution | |
| 14-522496 | In distribution | |
| 14-521656E | In distribution | |
| 14-521520 | Device Size Text, specify—4.0MM X 20MM FIXED SCREW | In distribution |
| 14-522126E | In distribution | |
| 14-521646BE | Device Size Text, specify—4.5 X16MM BLUNT VARIABLE SCREW | In distribution |
| 14-521516 | Device Size Text, specify—4.0MM X 16MM FIXED SCREW | In distribution |
| 14-521544B | Device Size Text, specify—4.5 X 14MM BLUNT FIXED SCREW | In distribution |
| 14-521538 | Device Size Text, specify—4.5MM X 8MM FIXED SCREW | In distribution |
| 14-521521 | Device Size Text, specify—4.0MM X 21MM FIXED SCREW | In distribution |
| 14-522448E | Device Size Text, specify—4 LEVEL 48MM FIXED PLATE | In distribution |
| 14-521626E | In distribution | |
| 14-521541 | Device Size Text, specify—4.5MM X 11MM FIXED SCREW | In distribution |
| 14-522118E | In distribution | |
| 14-522336E | Device Size Text, specify—3 LEVEL 36MM FIXED PLATE | In distribution |
| 14-522488E | Device Size Text, specify—4 LEVEL 88MM FIXED PLATE | In distribution |
| 14-521550E | In distribution | |
| 14-521547 | Device Size Text, specify—4.5MM X 17MM FIXED SCREW | In distribution |
| 14-521656BE | Device Size Text, specify—4.5 X26MM BLUNT VARIABLE SCREW | In distribution |
| 14-521514 | Device Size Text, specify—4.0MM X 14MM FIXED SCREW | In distribution |
| 14-521522 | Device Size Text, specify—4.0MM X 22MM FIXED SCREW | In distribution |
| 14-521514E | In distribution | |
| 14-522250E | Device Size Text, specify—2 LEVEL 50MM FIXED PLATE | In distribution |
| 14-521552B | Device Size Text, specify—4.5 X 22MM BLUNT FIXED SCREW | In distribution |
| 14-522339 | Device Size Text, specify—3 LEVEL 39MM FIXED PLATE | In distribution |
| 14-522226 | Device Size Text, specify—2 LEVEL 26MM FIXED PLATE | In distribution |
| 14-522476 | In distribution | |
| 14-521544 | Device Size Text, specify—4.5MM X 14MM FIXED SCREW | In distribution |
| 14-521640B | Device Size Text, specify—4.5 X10MM BLUNT VARIABLE SCREW | In distribution |
| 14-522110 | Device Size Text, specify—1 LEVEL 10MM FIXED PLATE | In distribution |
| 14-522220E | In distribution | |
| 14-521652E | In distribution | |
| 14-521512 | Device Size Text, specify—4.0MM X 12MM FIXED SCREW | In distribution |
| 14-521608B | Device Size Text, specify—4.0 X 8MM BLUNT VARIABLE SCREW | In distribution |
| 14-521542E | In distribution | |
| 14-522369 | In distribution | |
| 14-522140 | Device Size Text, specify—5-Level 60 mm Fixed Plate MAXAN | In distribution |
| 14-522366 | In distribution | |
| 14-522262E | Device Size Text, specify—2 LEVEL 62MM FIXED PLATE | In distribution |
| 14-521640E | In distribution | |
| 14-522360 | In distribution | |
| 14-522345E | Device Size Text, specify—3 LEVEL 45MM FIXED PLATE | In distribution |
| 14-521644BE | Device Size Text, specify—4.5 X14MM BLUNT VARIABLE SCREW | In distribution |
| 14-521515 | Device Size Text, specify—4.0MM X 15MM FIXED SCREW | In distribution |
| 14-522256 | Device Size Text, specify—2 LEVEL 56MM FIXED PLATE | In distribution |
| 14-521612B | Device Size Text, specify—4.0 X12MM BLUNT VARIABLE SCREW | In distribution |
| 14-521626B | Device Size Text, specify—4.0 X26MM BLUNT VARIABLE SCREW | In distribution |
| 14-522122E | In distribution | |
| 14-522387 | In distribution | |
| 14-522254 | Device Size Text, specify—2 LEVEL 54MM FIXED PLATE | In distribution |
| 14-522258 | Device Size Text, specify—2 LEVEL 58MM FIXED PLATE | In distribution |
| 14-521540E | In distribution | |
| 14-522464 | In distribution | |
| 14-521523 | Device Size Text, specify—4.0MM X 23MM FIXED SCREW | In distribution |
| 14-522348 | In distribution | |
| 14-522195 | Device Size Text, specify—5-Level 115 mm Fixed Plate MAXAN | In distribution |
| 14-521556B | Device Size Text, specify—4.5 X 26MM BLUNT FIXED SCREW | In distribution |
| 14-522230 | Device Size Text, specify—2 LEVEL 30MM FIXED PLATE | In distribution |
| 14-521626 | Device Size Text, specify—4.0MM X 26MM VARIABLE SCREW | In distribution |
| 14-521556 | Device Size Text, specify—4.5MM X 26MM FIXED SCREW | In distribution |
| 14-521656B | Device Size Text, specify—4.5 X26MM BLUNT VARIABLE SCREW | In distribution |
| 14-521546B | Device Size Text, specify—4.5 X 16MM BLUNT FIXED SCREW | In distribution |
| 14-522360E | Device Size Text, specify—3 LEVEL 60MM FIXED PLATE | In distribution |
| 14-522114 | Device Size Text, specify—1 LEVEL 14MM FIXED PLATE | In distribution |
| 14-521509 | Device Size Text, specify—4.0MM X 9MM FIXED SCREW | In distribution |
| 14-521618BE | Device Size Text, specify—4.0 X18MM BLUNT VARIABLE SCREW | In distribution |
| 14-522220 | Device Size Text, specify—2 LEVEL 20MM FIXED PLATE | In distribution |
| 14-521554BE | Device Size Text, specify—4.5MM X 24MM BLUNT FIXED SCREW | In distribution |
| 14-522345 | In distribution | |
| 14-521614 | Device Size Text, specify—4.0MM X 14MM VARIABLE SCREW | In distribution |
| 14-521524BE | Device Size Text, specify—4.0MM X 24MM BLUNT FIXED SCREW | In distribution |
| 14-521645 | Device Size Text, specify—4.5MM X 15MM VARIABLE SCREW | In distribution |
| 14-522244 | Device Size Text, specify—2 LEVEL 44MM FIXED PLATE | In distribution |
| 14-521508 | Device Size Text, specify—4.0MM X 8MM FIXED SCREW | In distribution |
| 14-522484E | Device Size Text, specify—4 LEVEL 84MM FIXED PLATE | In distribution |
| 14-521520E | In distribution | |
| 14-522170 | Device Size Text, specify—5-Level 90 mm Fixed Plate MAXAN | In distribution |
| 14-522452 | In distribution | |
| 14-521624B | Device Size Text, specify—4.0 X24MM BLUNT VARIABLE SCREW | In distribution |
| 14-522118 | Device Size Text, specify—1 LEVEL 18MM FIXED PLATE | In distribution |
| 14-522351E | Device Size Text, specify—3 LEVEL 51MM FIXED PLATE | In distribution |
| 14-522238 | Device Size Text, specify—2 LEVEL 38MM FIXED PLATE | In distribution |
| 14-521540 | Device Size Text, specify—4.5MM X 10MM FIXED SCREW | In distribution |
| 14-522342 | Device Size Text, specify—3 LEVEL 42MM FIXED PLATE | In distribution |
| 14-521625 | Device Size Text, specify—4.0MM X 25MM VARIABLE SCREW | In distribution |
| 14-521518E | In distribution | |
| 14-522264 | Device Size Text, specify—2 LEVEL 64MM FIXED PLATE | In distribution |
| 14-522238E | Device Size Text, specify—2 LEVEL 38MM FIXED PLATE | In distribution |
| 14-522180 | Device Size Text, specify—5-Level 100 mm Fixed Plate MAXAN | In distribution |
| 14-521638E | In distribution | |
| 14-521550BE | Device Size Text, specify—4.5MM X 20MM BLUNT FIXED SCREW | In distribution |
| 14-521652BE | Device Size Text, specify—4.5 X22MM BLUNT VARIABLE SCREW | In distribution |
| 14-521652B | Device Size Text, specify—4.5 X22MM BLUNT VARIABLE SCREW | In distribution |
| 14-521514B | Device Size Text, specify—4.0 X 14MM BLUNT FIXED SCREW | In distribution |
| 14-521616BE | Device Size Text, specify—4.0 X16MM BLUNT VARIABLE SCREW | In distribution |
| 14-522240E | Device Size Text, specify—2 LEVEL 40MM FIXED PLATE | In distribution |
| 14-522484 | In distribution | |
| 14-522108 | Device Size Text, specify—1 LEVEL 8MM FIXED PLATE | In distribution |
| 14-522256E | Device Size Text, specify—2 LEVEL 56MM FIXED PLATE | In distribution |
| 14-521516BE | Device Size Text, specify—4.0MM X 16MM BLUNT FIXED SCREW | In distribution |
| 14-522496E | Device Size Text, specify—4 LEVEL 96MM FIXED PLATE | In distribution |
| 14-522110E | In distribution | |
| 14-521614BE | Device Size Text, specify—4.0 X14MM BLUNT VARIABLE SCREW | In distribution |
| 14-521526 | Device Size Text, specify—4.0MM X 26MM FIXED SCREW | In distribution |
| 14-521518 | Device Size Text, specify—4.0MM X 18MM FIXED SCREW | In distribution |
| 14-521525 | Device Size Text, specify—4.0MM X 25MM FIXED SCREW | In distribution |
| 14-522113E | In distribution | |
| 14-522351 | In distribution | |
| 14-521620 | Device Size Text, specify—4.0MM X 20MM VARIABLE SCREW | In distribution |
| 14-521615 | Device Size Text, specify—4.0MM X 15MM VARIABLE SCREW | In distribution |
| 14-521608E | In distribution | |
| 14-522234 | Device Size Text, specify—2 LEVEL 34MM FIXED PLATE | In distribution |
| 14-521552E | In distribution | |
| 14-521643 | Device Size Text, specify—4.5MM X 13MM VARIABLE SCREW | In distribution |
| 14-521640BE | Device Size Text, specify—4.5 X10MM BLUNT VARIABLE SCREW | In distribution |
| 14-521524E | In distribution | |
| 14-522252E | Device Size Text, specify—2 LEVEL 52MM FIXED PLATE | In distribution |
| 14-521554E | In distribution | |
| 14-521623 | Device Size Text, specify—4.0MM X 23MM VARIABLE SCREW | In distribution |
| 14-522232 | Device Size Text, specify—2 LEVEL 32MM FIXED PLATE | In distribution |
| 14-521646B | Device Size Text, specify—4.5 X16MM BLUNT VARIABLE SCREW | In distribution |
| 14-522185 | Device Size Text, specify—5-Level 105 mm Fixed Plate MAXAN | In distribution |
| 14-522390E | Device Size Text, specify—3 LEVEL 90MM FIXED PLATE | In distribution |
| 14-522132 | Device Size Text, specify—1 LEVEL 32MM FIXED PLATE | In distribution |
| 14-522120 | Device Size Text, specify—1 LEVEL 20MM FIXED PLATE | In distribution |
| 14-522234E | Device Size Text, specify—2 LEVEL 34MM FIXED PLATE | In distribution |
| 14-522126 | Device Size Text, specify—1 LEVEL 26MM FIXED PLATE | In distribution |
| 14-521655 | Device Size Text, specify—4.5MM X 25MM VARIABLE SCREW | In distribution |
| 14-521644 | Device Size Text, specify—4.5MM X 14MM VARIABLE SCREW | In distribution |
| 14-522122 | Device Size Text, specify—1 LEVEL 22MM FIXED PLATE | In distribution |
| 14-521610B | Device Size Text, specify—4.0 X10MM BLUNT VARIABLE SCREW | In distribution |
| 14-521639 | Device Size Text, specify—4.5MM X 9MM VARIABLE SCREW | In distribution |
| 14-521624BE | Device Size Text, specify—4.0 X24MM BLUNT VARIABLE SCREW | In distribution |
| 14-522116E | In distribution | |
| 14-521550 | Device Size Text, specify—4.5MM X 20MM FIXED SCREW | In distribution |
| 14-521552 | Device Size Text, specify—4.5MM X 22MM FIXED SCREW | In distribution |
| 14-522448 | In distribution | |
| 14-522333E | Device Size Text, specify—3 LEVEL 33MM FIXED PLATE | In distribution |
| 14-522252 | Device Size Text, specify—2 LEVEL 52MM FIXED PLATE | In distribution |
| 14-522504 | In distribution | |
| 14-521514BE | Device Size Text, specify—4.0MM X 14MM BLUNT FIXED SCREW | In distribution |
| 14-522363 | In distribution | |
| 14-522270E | Device Size Text, specify—2 LEVEL 70MM FIXED PLATE | In distribution |
| 14-522357E | Device Size Text, specify—3 LEVEL 57MM FIXED PLATE | In distribution |
| 14-521508E | In distribution | |
| 14-521546BE | Device Size Text, specify—4.5MM X 16MM BLUNT FIXED SCREW | In distribution |
| 14-522381 | In distribution | |
| 14-521544E | In distribution | |
| 14-522268E | Device Size Text, specify—2 LEVEL 68MM FIXED PLATE | In distribution |
| 14-521650 | Device Size Text, specify—4.5MM X 20MM VARIABLE SCREW | In distribution |
| 14-521647 | Device Size Text, specify—4.5MM X 17MM VARIABLE SCREW | In distribution |
| 14-522476E | Device Size Text, specify—4 LEVEL 76MM FIXED PLATE | In distribution |
| 14-522460E | Device Size Text, specify—4 Level 60 mm Fixed Plate | In distribution |
| 14-521548BE | Device Size Text, specify—4.5MM X 18MM BLUNT FIXED SCREW | In distribution |
| 14-522111 | Device Size Text, specify—1 LEVEL 11MM FIXED PLATE | In distribution |
| 14-522336 | Device Size Text, specify—3 LEVEL 36MM FIXED PLATE | In distribution |
| 14-522165 | Device Size Text, specify—5-Level 85 mm Fixed Plate MAXAN | In distribution |
| 14-522342E | Device Size Text, specify—3 LEVEL 42MM FIXED PLATE | In distribution |
| 14-522480E | Device Size Text, specify—4 LEVEL 80MM FIXED PLATE | In distribution |
| 14-522480 | In distribution | |
| 14-522230E | Device Size Text, specify—2 LEVEL 30MM FIXED PLATE | 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
Recalls
3 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 |
|---|---|---|---|---|---|
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2015-09-29 | Class II | Labeling mix-ups | The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws. | 17 units | 2016-04-29 |
| 2015-08-05 | Class II | Labeling mix-ups | Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. | 7 parts | 2016-02-10 |
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.