MAALEABLE FACIAL IMPLANT— 510(k) K915445

Name: FDA 510(k) clearance K915445
Creator: U.S. Food and Drug Administration
Published: 1992-02-03

Substantially Equivalent

Biomet Ussc Orthopedics

FDA 510(k) clearance K915445 for MAALEABLE FACIAL IMPLANT, Substantially Equivalent on 1992-02-03. Applicant: Biomet Ussc Orthopedics. Device class: 2.

Clearance details

Applicant: Biomet Ussc Orthopedics
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1991-12-05
Decision date: 1992-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR2015-04-16
K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE2014-07-28

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