Identifiers
- 510(k) Number
- K080367 FDA 510(k)
- FDA Product Code
- FST FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4580 FDA 510(k)
- Regulation Number
- 878.4580 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zimmer MIS Light is a fiber optic surgical illumination device designed to provide light to a surgical site. It consists of fiber optic cables encased in silicone tubing that connect a hospital-provided high-intensity light source to a Zimmer surgical access instrument.
This device is provided sterile for single-use. It is regulated under FDA 510(k) clearance number K080367.
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: PDF z11u1er Zimmer® MIS Light spine 03 - accessdata.fda.gov, ZIMMER MIS LIGHT (K080367) — FDA 510 (k) | Innolitics, Zimmer Releases New MIS Spine Products - odtmag.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080367 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Spine, Inc.
Sources (1)
- FDA 510(k) K080367 24 fields · synced Sep 23, 2026