Biolign Roto-Loc Cervical Plate System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200523 FDA 510(k)
- FDA Product Code
- KWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biolign Roto-Loc Cervical Plate System is a device indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by degenerative disc disease or trauma. It is designed to provide anterior cervical plating support to facilitate spinal fusion procedures.
The system is supplied by Elite Surgical Supplies (Pty), Ltd. and has received FDA 510(k) clearance under K200523. It is intended for use in surgical settings and is not described as sterile, single-use, reusable, MRI safe, or having specific size variations in the provided data.
Frequently asked questions
What is the Biolign Roto-Loc Cervical Plate System used for?
The Biolign Roto-Loc Cervical Plate System is indicated for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by degenerative disc disease or trauma, providing anterior cervical plating support to facilitate spinal fusion procedures.
Is the Biolign Roto-Loc Cervical Plate System sterile or single-use?
The provided data does not describe the Biolign Roto-Loc Cervical Plate System as sterile, single-use, or reusable; therefore, no information about its sterility or single-use status is available from the device specifications.
What regulatory pathway was used for the Biolign Roto-Loc Cervical Plate System?
The Biolign Roto-Loc Cervical Plate System received FDA 510(k) clearance under K200523, with a traditional clearance type and a substantially equivalent decision, as indicated by the decision code SESE and decision description.
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: Biolign® Roto-Loc Cervical Plate System (K200523) — FDA 510 (k ..., K200523 FDA 510(k) - Biolign Roto-Loc Cervical Plate System, Roto-Loc - Elite Surgical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200523 | Class II | Active |
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Manufacturer
- Manufacturer
- Elite Surgical Supplies (pty) Ltd
- FDA Applicant
- Elite Surgical Supplies (Pty), Ltd.
Sources (1)
- FDA 510(k) K200523 24 fields · synced Oct 6, 2026