AVANTA ORTHOPAEDICS TENDON SPACER— 510(k) K964359

Name: FDA 510(k) clearance K964359
Creator: U.S. Food and Drug Administration
Published: 1997-03-25

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K964359 for AVANTA ORTHOPAEDICS TENDON SPACER, Substantially Equivalent on 1997-03-25. Applicant: Avanta Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Avanta Orthopaedics, Inc.
Product code: Code HXA
Device class: Class 2
Regulation: 21 CFR 888.3025
Advisory panel: Orthopedic
Date received: 1996-11-01
Decision date: 1997-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXA

view all

K243477 — Universal Tendon Spacer2025-01-10
K000019 — SINGLE SIZE TENDON SPACER2000-03-29
K973385 — OVAL SHAPES1997-12-05
K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES1993-12-30
K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC1987-09-28

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.