UNIVERSAL CLAMP SPINAL FIXATION SYSTEM— 510(k) K110348

Name: FDA 510(k) clearance K110348
Creator: U.S. Food and Drug Administration
Published: 2011-08-11

Substantially Equivalent

Zimmer Spine

FDA 510(k) clearance K110348 for UNIVERSAL CLAMP SPINAL FIXATION SYSTEM, Substantially Equivalent on 2011-08-11. Applicant: Zimmer Spine. Device class: 2.

Clearance details

Applicant: Zimmer Spine
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2011-02-07
Decision date: 2011-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.