Hallmark
66MM Three Level Cervical Plate Assembly, Hallmark Acps
14manufacturers in China registered for this device type
90catalogue numbers in this listing
1510(k) clearance
1recall
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 | Orthofix US 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100614 |
| Record published | 2017-08-01 |
| Record revised | 2026-02-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 10 to 125 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 62-6220 | Length 22 mm | In distribution |
| 62-6520 | Length 52 mm | In distribution |
| 62-6511 | Length 110 mm | In distribution |
| 62-6106 | Length 106 mm | In distribution |
| 62-6640 | Length 64 mm | In distribution |
| 62-2160 | Length 16 mm | In distribution |
| 62-6560 | Length 56 mm | In distribution |
| 62-6660 | In distribution | |
| 62-6362 | Length 36 mm | In distribution |
| 62-6360 | Length 36 mm | In distribution |
| 62-6240 | Length 24 mm | In distribution |
| 62-6114 | Length 114 mm | In distribution |
| 450239-0001 | In distribution | |
| 62-6118 | In distribution | |
| 62-6744 | In distribution | |
| 62-1160 | Length 16 mm | In distribution |
| 62-6300 | Length 30 mm | In distribution |
| 62-6820 | In distribution | |
| 62-6420 | Length 42 mm | In distribution |
| 62-6105 | Length 105 mm | In distribution |
| 62-6122 | Length 122 mm | In distribution |
| 62-1120 | Length 12 mm | In distribution |
| 62-3120 | Length 12 mm | In distribution |
| 62-1100 | Length 10 mm | In distribution |
| 62-6904 | In distribution | |
| 62-6340 | Length 34 mm | In distribution |
| 62-6120 | Length 120 mm | In distribution |
| 62-4140 | Length 14 mm | In distribution |
| 62-6864 | In distribution | |
| 62-6624 | Length 62 mm | In distribution |
| 62-6940 | In distribution | |
| 62-6115 | Length 115 mm | In distribution |
| 62-6460 | Length 46 mm | In distribution |
| 62-6664 | In distribution | |
| 62-6950 | In distribution | |
| 62-4100 | Length 10 mm | In distribution |
| 62-2120 | Length 12 mm | In distribution |
| 62-6320 | Length 32 mm | In distribution |
| 62-3000 | In distribution | |
| 62-6483 | Length 48 mm | In distribution |
| 62-1180 | Length 18 mm | In distribution |
| 62-6860 | In distribution | |
| 62-6200 | Length 20 mm | In distribution |
| 62-4180 | Length 18 mm | In distribution |
| 62-6704 | In distribution | |
| 62-6644 | In distribution | |
| 62-6102 | Length 102 mm | In distribution |
| 62-6980 | In distribution | |
| 62-6780 | In distribution | |
| 62-2180 | Length 18 mm | In distribution |
| 62-3100 | Length 10 mm | In distribution |
| 62-3180 | Length 18 mm | In distribution |
| 62-6540 | Length 54 mm | In distribution |
| 62-4160 | Length 16 mm | In distribution |
| 62-6784 | In distribution | |
| 62-6850 | In distribution | |
| 62-3140 | Length 14 mm | In distribution |
| 62-6523 | Length 52 mm | In distribution |
| 62-6700 | In distribution | |
| 62-6503 | In distribution | |
| 62-6480 | Length 48 mm | In distribution |
| 62-6500 | Length 50 mm | In distribution |
| 62-6740 | In distribution | |
| 62-6684 | In distribution | |
| 62-6724 | In distribution | |
| 62-4120 | Length 12 mm | In distribution |
| 62-6440 | Length 44 mm | In distribution |
| 62-6680 | In distribution | |
| 62-6900 | In distribution | |
| 62-3010 | In distribution | |
| 62-6100 | Length 100 mm | In distribution |
| 62-3160 | Length 16 mm | In distribution |
| 62-6400 | Length 40 mm | In distribution |
| 62-6110 | Length 110 mm | In distribution |
| 62-6800 | In distribution | |
| 62-6280 | Length 28 mm | In distribution |
| 62-6543 | In distribution | |
| 62-6380 | Length 38 mm | In distribution |
| 450240-0001 | In distribution | |
| 62-6824 | In distribution | |
| 62-2100 | Length 10 mm | In distribution |
| 62-6620 | Length 62 mm | In distribution |
| 62-2140 | Length 14 mm | In distribution |
| 62-6600 | Length 60 mm | In distribution |
| 62-6342 | Length 34 mm | In distribution |
| 62-1140 | Length 14 mm | In distribution |
| 62-6580 | Length 58 mm | In distribution |
| 62-6125 | Length 125 mm | In distribution |
| 62-6260 | Length 26 mm | In distribution |
| 62-6905 | In distribution |
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 |
|---|---|
| K211712 | 2022-02-11 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2013-10-29 | Class II | Component design/selection | There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. | 4,172 units | 2014-12-09 |
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.