Diamondback
The FDA filing describes the Diamondback Spinal System as rods, monoaxial and polyaxial screws with caps, and cross connectors with lock screws. Its stated use is immobilization and…
The FDA filing describes the Diamondback Spinal System as rods, monoaxial and polyaxial screws with caps, and cross connectors with lock screws.
Its stated use is immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients.
Device Description and Stated Use
The summary identifies titanium alloy components and posterior pedicle fixation indications, including specified noncervical spinal instability and deformity conditions.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Eminent Spine, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K100377 |
| Record published | 2017-02-13 |
| Record revised | 2025-07-02 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DBRR5040 | In distribution | |
| DBRR7535 | In distribution | |
| DBRR4530 | In distribution | |
| DBR5540 | In distribution | |
| DBR7555 | In distribution | |
| DBRR5530 | In distribution | |
| DBRR7545 | In distribution | |
| DBR5030 | In distribution | |
| DBRR6545 | In distribution | |
| DBR6545 | In distribution | |
| DBRR4540 | In distribution | |
| DBRR5555 | In distribution | |
| DBR5530 | In distribution | |
| DBRR5035 | In distribution | |
| DBRR5540 | In distribution | |
| DBRR7560 | In distribution | |
| DBR6535 | In distribution | |
| DBRR6535 | In distribution | |
| DBRR5025 | In distribution | |
| DBRR6555 | In distribution | |
| DBRR4545 | In distribution | |
| DBR5525 | In distribution | |
| DBRR4535 | In distribution | |
| DBR5535 | In distribution | |
| DBR5545 | In distribution | |
| DBCR7560 | In distribution | |
| DBRR5525 | In distribution | |
| DBRR5030 | In distribution | |
| DBRR6550 | In distribution | |
| DBR7535 | In distribution | |
| DBR5550 | In distribution | |
| DBRR7530 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100377 | 2010-04-22 |
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.