ULNAR HEAD IMPLANT— 510(k) K982268

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K982268 for ULNAR HEAD IMPLANT, Substantially Equivalent on 1998-12-04. Applicant: Avanta Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Avanta Orthopaedics, Inc.
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 1998-06-29
Decision date: 1998-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXE

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K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT2008-10-24

More clearances from Avanta Orthopaedics, Inc.

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.