K'FIX— 510(k) K010847

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K010847 for K'FIX, Substantially Equivalent on 2001-06-19. Applicant: Avanta Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: Avanta Orthopaedics, Inc.
Product code: Code NDL
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2001-03-21
Decision date: 2001-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K011819 — RADIAL HEAD IMPLANT2001-06-19

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