BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143— 510(k) K960363

Name: FDA 510(k) clearance K960363
Creator: U.S. Food and Drug Administration
Published: 1997-02-18

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K960363 for BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143, Substantially Equivalent on 1997-02-18. Applicant: Biomet, Inc.. Device class: 3.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MJT
Device class: Class 3
Advisory panel: Unknown
Date received: 1996-01-25
Decision date: 1997-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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