REPICCI II UNICONDYLAR KNEE

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Repicci Ii Unicondylar Knee.

Pre-market Notification Details

• Device ID: K971938
• 510k Number: K971938
• Device Name: REPICCI II UNICONDYLAR KNEE
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia Sandborn Beres
• Correspondent: Patricia Sandborn Beres; BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-27
• Decision Date: 1997-08-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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