REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT

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

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Repicci Ii Metal Back Inlay Unicompartmental Tibial Bearing Component.

Pre-market Notification Details

• Device ID: K061681
• 510k Number: K061681
• Device Name: REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587
• Contact: Lester F Padilla
• Correspondent: Lester F Padilla; BIOMET MANUFACTURING CORP. PO 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: 2006-06-15
• Decision Date: 2006-10-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304652835	K061681	000
00880304652736	K061681	000
00880304652743	K061681	000
00880304652750	K061681	000
00880304652767	K061681	000
00880304652774	K061681	000
00880304652781	K061681	000
00880304652798	K061681	000
00880304652804	K061681	000
00880304652811	K061681	000
00880304652828	K061681	000
00880304652729	K061681	000