Nakoma-SL ACP System
Cervical Plating System 5-Level 100mm Plate
14manufacturers in China registered for this device type
40catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Alliance Partners, LLC, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| 510(k) | K141993 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (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 |
| Sizes | Length 12 to 105 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3100I-2000 | Length 26 mm | In distribution |
| 3100I-1006 | Length 24 mm | In distribution |
| 3100I-1004 | Length 20 mm | In distribution |
| 3100I-5004 | Length 95 mm | In distribution |
| 3100I-3002 | Length 46 mm | In distribution |
| 3100I-4002 | Length 68 mm | In distribution |
| 3100I-3001 | Length 43 mm | In distribution |
| 3100I-2003 | Length 32 mm | In distribution |
| 3100I-4004 | Length 76 mm | In distribution |
| 3100I-2001 | Length 28 mm | In distribution |
| 3100I-3003 | Length 49 mm | In distribution |
| 3100I-4005 | Length 80 mm | In distribution |
| 3100I-1002 | Length 16 mm | In distribution |
| 3100I-5000 | Length 75 mm | In distribution |
| 3100I-4001 | Length 64 mm | In distribution |
| 3100I-2007 | Length 43 mm | In distribution |
| 3100I-2004 | Length 34 mm | In distribution |
| 3100I-1003 | Length 18 mm | In distribution |
| 3100I-3004 | Length 52 mm | In distribution |
| 3100I-4006 | Length 84 mm | In distribution |
| 3100I-1001 | Length 14 mm | In distribution |
| 3100I-5001 | Length 80 mm | In distribution |
| 3100I-3005 | Length 55 mm | In distribution |
| 3100I-5002 | Length 85 mm | In distribution |
| 3100I-3007 | Length 61 mm | In distribution |
| 3100I-5005 | Length 100 mm | In distribution |
| 3100I-4000 | Length 60 mm | In distribution |
| 3100I-1005 | Length 22 mm | In distribution |
| 3100I-3008 | Length 64 mm | In distribution |
| 3100I-5003 | Length 90 mm | In distribution |
| 3100I-2005 | Length 37 mm | In distribution |
| 3100I-3000 | Length 40 mm | In distribution |
| 3100I-1000 | Length 12 mm | In distribution |
| 3100I-3006 | Length 58 mm | In distribution |
| 3100I-2006 | Length 40 mm | In distribution |
| 3100I-2008 | Length 46 mm | In distribution |
| 3100I-2002 | Length 30 mm | In distribution |
| 3100I-3009 | Length 67 mm | In distribution |
| 3100I-5006 | Length 105 mm | In distribution |
| 3100I-4003 | Length 72 mm | 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 |
|---|---|
| K201521 | 2020-08-06 |
| K141993 | 2014-11-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alliance Partners, LLC | 510(k) number | 2015-06-09 | Class II | Device Design | Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation. | 21 units | 2015-10-09 |
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.