Nakoma ACP System
Cervical Plating System 4.0x15mm Variable Self-Drilling Screw
14manufacturers in China registered for this device type
80catalogue 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 10 to 20 mm; outer diameter 4 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3100I-8508 | Length 20 mm | In distribution |
| 3100I-6005 | Outer Diameter 4 mm | In distribution |
| 3100I-9006 | Outer Diameter 4 mm | In distribution |
| 3100I-9502 | Outer Diameter 4.5 mm | In distribution |
| 3100I-6001 | Length 11 mm | In distribution |
| 3100I-7005 | Length 15 mm | In distribution |
| 3100I-8004 | Outer Diameter 4 mm | In distribution |
| 3100I-7007 | Outer Diameter 4 mm | In distribution |
| 3100I-8008 | Outer Diameter 4 mm | In distribution |
| 3100I-8501 | Length 13 mm | In distribution |
| 3100I-8506 | Length 18 mm | In distribution |
| 3100I-9007 | Outer Diameter 4 mm | In distribution |
| 3100I-7506 | Length 18 mm | In distribution |
| 3100I-7002 | Length 12 mm | In distribution |
| 3100I-6007 | Outer Diameter 4 mm | In distribution |
| 3100I-9501 | Outer Diameter 4.5 mm | In distribution |
| 3100I-6002 | Length 12 mm | In distribution |
| 3100I-8504 | Length 16 mm | In distribution |
| 3100I-6008 | Length 18 mm | In distribution |
| 3100I-9002 | Outer Diameter 4 mm | In distribution |
| 3100I-6000 | Length 10 mm | In distribution |
| 3100I-9504 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7502 | Length 14 mm | In distribution |
| 3100I-9506 | Length 18 mm | In distribution |
| 3100I-7505 | Outer Diameter 4.5 mm | In distribution |
| 3100I-9505 | Length 17 mm | In distribution |
| 3100I-8005 | Length 15 mm | In distribution |
| 3100I-6004 | Length 14 mm | In distribution |
| 3100I-6006 | Outer Diameter 4 mm | In distribution |
| 3100I-6507 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7000 | Length 10 mm | In distribution |
| 3100I-6010 | Length 20 mm | In distribution |
| 3100I-7504 | Outer Diameter 4.5 mm | In distribution |
| 3100I-8502 | Outer Diameter 4.5 mm | In distribution |
| 3100I-6506 | Length 18 mm | In distribution |
| 3100I-8009 | Outer Diameter 4 mm | In distribution |
| 3100I-7507 | Outer Diameter 4.5 mm | In distribution |
| 3100I-8503 | Length 15 mm | In distribution |
| 3100I-9500 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7501 | Outer Diameter 4.5 mm | In distribution |
| 3100I-9010 | Length 20 mm | In distribution |
| 3100I-7503 | Length 15 mm | In distribution |
| 3100I-8500 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7004 | Length 14 mm | In distribution |
| 3100I-9000 | Length 10 mm | In distribution |
| 3100I-7010 | Outer Diameter 4 mm | In distribution |
| 3100I-9001 | Outer Diameter 4 mm | In distribution |
| 3100I-6503 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7003 | Outer Diameter 4 mm | In distribution |
| 3100I-6505 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7001 | Outer Diameter 4 mm | In distribution |
| 3100I-9004 | Length 14 mm | In distribution |
| 3100I-9508 | Outer Diameter 4.5 mm | In distribution |
| 3100I-9005 | Length 15 mm | In distribution |
| 3100I-8007 | Length 17 mm | In distribution |
| 3100I-9503 | Length 15 mm | In distribution |
| 3100I-8002 | Length 12 mm | In distribution |
| 3100I-8505 | Outer Diameter 4.5 mm | In distribution |
| 3100I-7008 | Outer Diameter 4 mm | In distribution |
| 3100I-8010 | Length 20 mm | In distribution |
| 3100I-7508 | Outer Diameter 4.5 mm | In distribution |
| 3100I-8000 | Outer Diameter 4 mm | In distribution |
| 3100I-6508 | Length 20 mm | In distribution |
| 3100I-9507 | Length 19 mm | In distribution |
| 3100I-8003 | Outer Diameter 4 mm | In distribution |
| 3100I-7006 | Outer Diameter 4 mm | In distribution |
| 3100I-8006 | Outer Diameter 4 mm | In distribution |
| 3100I-6003 | Outer Diameter 4 mm | In distribution |
| 3100I-6501 | Outer Diameter 4.5 mm | In distribution |
| 3100I-9009 | Outer Diameter 4 mm | In distribution |
| 3100I-6500 | Length 12 mm | In distribution |
| 3100I-6502 | Outer Diameter 4.5 mm | In distribution |
| 3100I-9003 | Outer Diameter 4 mm | In distribution |
| 3100I-7500 | Length 12 mm | In distribution |
| 3100I-6009 | Outer Diameter 4 mm | In distribution |
| 3100I-8001 | Length 11 mm | In distribution |
| 3100I-6504 | Outer Diameter 4.5 mm | In distribution |
| 3100I-8507 | Length 19 mm | In distribution |
| 3100I-9008 | Outer Diameter 4 mm | In distribution |
| 3100I-7009 | Outer Diameter 4 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.