AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT— 510(k) K965204

Name: FDA 510(k) clearance K965204
Creator: U.S. Food and Drug Administration
Published: 1997-06-03

Substantially Equivalent for Some Indications

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K965204 for AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT, Substantially Equivalent for Some Indications on 1997-06-03. 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: 1996-12-26
Decision date: 1997-06-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYI

view all

K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 1612020-12-02
K180744 — Stablyx CMC Arthroplasty Implant System2018-04-11
K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 52011-12-30
K112278 — ASCENSION NUGRIP CMC IMPLANT2011-11-04
K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS2009-12-15

More clearances from Avanta Orthopaedics, Inc.

view all

K030881 — AVANTA CARPAL FUSION PLATING SYSTEM2003-04-10
K021859 — WRIST IMPLANT2002-12-02
K023604 — MODIFICATION TO RADIAL HEAD IMPLANT2002-11-27
K013629 — FINGER JOINT PROSTHESIS2002-01-25
K010847 — K'FIX2001-06-19

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