Acumen Thoracolumbar Plate System
Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL WITH RIDGE, FLAT, 20mm
14manufacturers in China registered for this device type
128catalogue numbers in this listing
3510(k) clearances naming this product 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 | Curiteva, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K233360 |
| Record published | 2024-10-31 |
| Record revised | 2025-11-20 (version 2) |
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 15 to 40 mm; outer diameter 3 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C1154-5035-VST | Length 35 mm | In distribution |
| C1154-5535-FST | Length 35 mm | In distribution |
| C1155-311 | Length 15 mm | In distribution |
| C1154-0224-BR | Length 24 mm | In distribution |
| C1154-0128 | Length 28 mm | In distribution |
| C1154-0426 | Length 26 mm | In distribution |
| C1154-0416 | Length 16 mm | In distribution |
| C1154-0220-SR | Length 20 mm | In distribution |
| C1154-5040-VSD | Length 40 mm | In distribution |
| C1154-0226-SR | Length 26 mm | In distribution |
| C1154-0226 | Length 26 mm | In distribution |
| C1154-5020-FSD | Length 20 mm | In distribution |
| C1154-0222-SR | Length 22 mm | In distribution |
| C1154-0120 | Length 20 mm | In distribution |
| C1154-0420-S | Length 20 mm | In distribution |
| C1155-400-15 | Outer Diameter 3.0 mm | In distribution |
| C1154-5530-VST | Length 30 mm | In distribution |
| C1154-5525-FST | Length 25 mm | In distribution |
| C1154-0218-BR | Length 18 mm | In distribution |
| C1154-0232 | Length 32 mm | In distribution |
| C1154-0232-SR | Length 32 mm | In distribution |
| C1154-0432 | Length 32 mm | In distribution |
| C1154-5530-VSD | Length 30 mm | In distribution |
| C1154-0418 | Length 18 mm | In distribution |
| C1154-5020-FST | Length 20 mm | In distribution |
| C1154-0222-S | Length 22 mm | In distribution |
| C1154-5020-VSD | Length 20 mm | In distribution |
| C1154-5030-VST | Length 30 mm | In distribution |
| C1154-0416-S | Length 16 mm | In distribution |
| C1154-0422-S | Length 22 mm | In distribution |
| C1155-300 | In distribution | |
| C1154-5530-FSD | Length 30 mm | In distribution |
| C1154-5040-FST | Length 40 mm | In distribution |
| C1155-101 | In distribution | |
| C1154-5030-FSD | Length 30 mm | In distribution |
| C1154-5040-FSD | Outer Diameter 5.0 mm | In distribution |
| C1154-5525-FSD | Length 25 mm | In distribution |
| C1154-0420-SR | Length 20 mm | In distribution |
| C1154-0224 | Length 24 mm | In distribution |
| C1154-5020-VST | Length 20 mm | In distribution |
| C1154-0222-BR | Length 22 mm | In distribution |
| C1154-0416-SR | Length 16 mm | In distribution |
| C1154-0430-SR | Length 30 mm | In distribution |
| C1155-156 | In distribution | |
| C1155-800 | In distribution | |
| C1155-120 | In distribution | |
| C1154-0218-S | Length 18 mm | In distribution |
| C1154-0232-BR | Length 32 mm | In distribution |
| C1154-0228 | Length 28 mm | In distribution |
| C1154-0228-S | Length 28 mm | In distribution |
| C1154-0428-SR | Length 28 mm | In distribution |
| C1154-0230-BR | Length 30 mm | In distribution |
| C1154-0224-S | Length 24 mm | In distribution |
| C1154-0232-S | Length 32 mm | In distribution |
| C1154-5530-FST | Length 30 mm | In distribution |
| C1154-0424 | Length 24 mm | In distribution |
| C1154-5525-VST | Length 25 mm | In distribution |
| C1154-0230 | Length 30 mm | In distribution |
| C1154-0220-S | Length 20 mm | In distribution |
| C1154-5030-VSD | Length 30 mm | In distribution |
| C1154-5035-VSD | Length 30 mm | In distribution |
| C1154-5520-VST | Length 20 mm | In distribution |
| C1154-0420 | Length 20 mm | In distribution |
| C1155-1005 | In distribution | |
| C1154-0216 | Length 16 mm | In distribution |
| C1154-5535-VST | Length 35 mm | In distribution |
| C1154-5025-FST | Length 25 mm | In distribution |
| C1154-0222 | Length 22 mm | In distribution |
| C1155-100 | In distribution | |
| C1154-0430-S | Length 30 mm | In distribution |
| C1155-150 | In distribution | |
| C1154-0226-BR | Length 26 mm | In distribution |
| C1154-0426-SR | Length 26 mm | In distribution |
| C1154-5035-FST | Length 35 mm | In distribution |
| C1154-0422-SR | Length 22 mm | In distribution |
| C1154-5040-VST | Length 40 mm | In distribution |
| C1154-0418-SR | Length 18 mm | In distribution |
| C1154-0428 | Length 28 mm | In distribution |
| C1154-0230-S | Length 30 mm | In distribution |
| C1154-0224-SR | Length 24 mm | In distribution |
| C1154-5540-FST | Length 40 mm | In distribution |
| C1154-0216-S | Length 16 mm | In distribution |
| C1154-0228-SR | Length 28 mm | In distribution |
| C1154-0428-S | Length 28 mm | In distribution |
| C1154-0230-SR | Length 30 mm | In distribution |
| C1154-0226-S | Length 26 mm | In distribution |
| C1155-130 | In distribution | |
| C1154-5535-FSD | Length 35 mm | In distribution |
| C1155-321 | Length 15 mm | In distribution |
| C1154-0124 | Length 24 mm | In distribution |
| C1155-410 | Outer Diameter 3.0 mm | In distribution |
| C1154-0220-BR | Length 20 mm | In distribution |
| C1155-500-25 | Outer Diameter 3.0 mm | In distribution |
| C1155-500-40 | Outer Diameter 3.0 mm | In distribution |
| C1155-500-20 | Outer Diameter 3.0 mm | In distribution |
| C1155-500-35 | Outer Diameter 3.0 mm | In distribution |
| C1154-5520-VSD | Length 20 mm | In distribution |
| C1154-5520-FST | Length 20 mm | In distribution |
| C1154-5025-VSD | Length 25 mm | In distribution |
| C1154-5525-VSD | Length 25 mm | In distribution |
| C1155-500-30 | Outer Diameter 3.0 mm | In distribution |
| C1154-0422 | Length 22 mm | In distribution |
| C1154-5540-VST | Length 40 mm | In distribution |
| C1154-0216-SR | Length 16 mm | In distribution |
| C1154-0218 | Length 18 mm | In distribution |
| C1154-5520-FSD | Length 20 mm | In distribution |
| C1154-0218-SR | Length 18 mm | In distribution |
| C1154-0432-S | Length 32 mm | In distribution |
| C1154-0424-SR | Length 24 mm | In distribution |
| C1154-5540-FSD | Length 40 mm | In distribution |
| C1155-1015 | In distribution | |
| C1154-0418-S | Length 18 mm | In distribution |
| C1154-5535-VSD | Length 35 mm | In distribution |
| C1154-0430 | Length 30 mm | In distribution |
| C1154-5025-VST | Length 25 mm | In distribution |
| C1154-5030-FST | Length 30 mm | In distribution |
| C1154-0220 | Length 20 mm | In distribution |
| C1154-0426-S | Length 26 mm | In distribution |
| C1154-5035-FSD | Outer Diameter 5.0 mm | In distribution |
| C1154-0228-BR | Length 28 mm | In distribution |
| C1154-0424-S | Length 24 mm | In distribution |
| C1154-0432-SR | Length 32 mm | In distribution |
| C1154-0216-BR | Length 16 mm | In distribution |
| C1155-900 | In distribution | |
| C1155-810 | In distribution | |
| C1154-5025-FSD | Length 25 mm | In distribution |
| C1155-700 | In distribution | |
| C1154-5540-VSD | Length 40 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 |
|---|---|
| K233360 | 2024-02-29 |
| K181549 | 2018-08-03 |
| K181562 | 2018-08-02 |
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.