Black Diamond Pedicle Screw System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192121 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Black Diamond Pedicle Screw System is a thoracolumbar fixation system designed for use in both minimally invasive and open procedures to treat a diverse array of pathologies. It is a versatile implant system intended for spinal stabilization and fusion.
The system is supplied non-sterile and is intended for single-use. It is available in various sizes as specified in the device specifications. The device received FDA 510(k) clearance (K192121) and is classified under product code NKB with advisory committee designation OR (Orthopedic).
Frequently asked questions
What is the Black Diamond Pedicle Screw System intended for?
The Black Diamond Pedicle Screw System is a thoracolumbar fixation system designed for use in both minimally invasive and open procedures to treat a diverse array of pathologies. It is intended for spinal stabilization and fusion, as stated in the device description.
How is the Black Diamond Pedicle Screw System supplied and is it reusable?
The system is supplied non-sterile and is intended for single-use only, meaning it should not be reprocessed or reused after initial implantation. This is explicitly stated in the device description under supply and intended use.
What regulatory pathway was used for the Black Diamond Pedicle Screw System?
The device received FDA 510(k) clearance under submission number K192121, as indicated in the AUTHORIZATIONS and SPECIFICATIONS fields. It was cleared via the traditional 510(k) pathway and found substantially equivalent to a predicate device.
What product code and advisory committee designation apply to the Black Diamond Pedicle Screw System?
The device is classified under product code NKB and has an advisory committee designation of OR (Orthopedic), as specified in the SPECIFICATIONS section under product_code and advisory_committee fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Black Diamond PSS - Osseus Fusion Systems, Osseus - Osseus Fusion Systems, Osseus Black Diamond PSS Pedicle Screw System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192121 | Class II | Active |
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Manufacturer
- Manufacturer
- Osseus Fusion Systems
Sources (1)
- FDA 510(k) K192121 24 fields · synced Sep 19, 2026