AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT— 510(k) K964381

Name: FDA 510(k) clearance K964381
Creator: U.S. Food and Drug Administration
Published: 1997-01-22

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K964381 for AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT, Substantially Equivalent on 1997-01-22. Applicant: Avanta Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Avanta Orthopaedics, Inc.
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 1996-11-04
Decision date: 1997-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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