Plus Pivot Link Universal System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K021507 FDA 510(k)
- FDA Product Code
- KWP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3050 FDA 510(k)
- Regulation Number
- 888.3050 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Plus Pivot Link Universal System is a spinal instrumentation set comprising hooks, screws, rods, and connectors that surgeons assemble into constructs tailored to specific spinal pathologies. It provides mechanical immobilization to facilitate fusion in acute or chronic spinal instabilities.
The system is used in clinical or operating room settings for posterior spinal fixation and stabilization. It is supplied as a universal system with various components for assembly. The device has FDA 510(k) clearance with number K021507.
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: PLUS PIVOT LINK UNIVERSAL SYSTEM (K021507) - Innolitics, PLUS PIVOT LINK UNIVERSAL SYSTEM 510 (k) K033508 - FDA.report, Plus Pivot Link Universal System 510 (k) FDA Premarket Notification ..., PDF QU1 IFU RevAB 2023-01-05
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021507 | Class II | Active |
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Manufacturer
- Manufacturer
- Spine Vision, Inc.
Sources (1)
- FDA 510(k) K021507 24 fields · synced Sep 22, 2026