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Sign in to claim this brandBOXSPINE HOLDINGS, INC.
US
Last updated May 25, 2026
What BOXSPINE HOLDINGS, INC. makes
The company manufactures spinal fixation hardware, including non-bioabsorbable bone screws, internal fixation rods, and reusable orthopaedic positioning instruments for prosthesis implantation. It also produces connectors designed for spinal fixation systems, ensuring stability in orthopaedic procedures.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for spinal and orthopaedic implants.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does BoxSpine Holdings, Inc. manufacture?
BoxSpine Holdings, Inc. specializes in spinal fixation hardware, including non-bioabsorbable bone screws, internal spinal fixation rods, and reusable orthopaedic instruments for positioning implants. They also produce connectors that help stabilize spinal fixation systems. These devices are designed to support orthopaedic procedures, particularly for spinal stability.
Where is BoxSpine Holdings, Inc. based, and does this affect its devices?
BoxSpine Holdings, Inc. is based in the United States, which means its devices must comply with FDA regulations. The company’s location ensures its products meet U.S. standards for safety, performance, and manufacturing practices, particularly for spinal and orthopaedic implants. This alignment with FDA requirements also influences how its devices are classified and registered.
Which regulatory registries list BoxSpine Holdings, Inc.’s devices?
BoxSpine Holdings, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and market surveillance. This listing is essential for traceability and adherence to FDA requirements.
How are BoxSpine Holdings, Inc.’s devices classified by the FDA?
BoxSpine Holdings, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and benefits, as outlined in FDA guidelines.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 126547906
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pls | 06.6420B-K | FDA UDI | Class II | Active |
| Pls | 06.6430B | FDA UDI | Class II | Active |
| Pls | 06.6394B-K | FDA UDI | Class II | Active |
| Pls | 06.6362B-K | FDA UDI | Class II | Active |
| Pls | 06.6417B-K | FDA UDI | Class II | Active |
| B2B Instruments | 09.0728PK | FDA UDI | Class I | Active |
| Pls | 06.6361B-K | FDA UDI | Class II | Active |
| Pls | 06.6433B | FDA UDI | Class II | Active |
| B2B Instruments | 09.0512PK | FDA UDI | Class I | Active |
| Pls | 06.6395B-K | FDA UDI | Class II | Active |
| Pls | 06.6449B | FDA UDI | Class II | Active |
| Pls | 06.6429B | FDA UDI | Class II | Active |
| Pls | 06.6384B-K | FDA UDI | Class II | Active |
| Pls | 06.6418B-K | FDA UDI | Class II | Active |
| Pls | 06.6432B | FDA UDI | Class II | Active |
| Pls | 06.6441B | FDA UDI | Class II | Active |
| Pls | 06.6365B-K | FDA UDI | Class II | Active |
| Pls | 06.6439B | FDA UDI | Class II | Active |
| Pls | 06.6447B | FDA UDI | Class II | Active |
| Pls | 06.6382B-K | FDA UDI | Class II | Active |
| Pls | 06.6440B | FDA UDI | Class II | Active |
| Pls | 06.6381B-K | FDA UDI | Class II | Active |
| Pls | 06.6416B-K | FDA UDI | Class II | Active |
| Pls | 06.6434B | FDA UDI | Class II | Active |
| Pls | 06.6419B-K | FDA UDI | Class II | Active |
| Pls | 06.6363B-K | FDA UDI | Class II | Active |
| Pls | 06.6448B | FDA UDI | Class II | Active |
| B2B Instruments | 09.0729PK | FDA UDI | Class I | Active |
| Pls | 06.6438B | FDA UDI | Class II | Active |
| Spine Instruments | 09.0799PK | FDA UDI | Class I | Active |
| Pls | 06.6380B-K | FDA UDI | Class II | Active |
| Pls | 06.6421B-K | FDA UDI | Class II | Active |
| Pls | 06.6364B-K | FDA UDI | Class II | Active |
| Pls | 06.6383B-K | FDA UDI | Class II | Active |
| Pls | 06.6396B-K | FDA UDI | Class II | Active |
| Pls | 06.6393B-K | FDA UDI | Class II | Active |
| Pls | 06.6431B | FDA UDI | Class II | Active |
| Pls | 06.6437B | FDA UDI | Class II | Active |
| Pls | 06.6435B | FDA UDI | Class II | Active |
| Pls | 06.6442B | FDA UDI | Class II | Active |
| Pls | 06.6436B | FDA UDI | Class II | Active |
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