OFFSET TIBIAL TRAY

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Offset Tibial Tray.

Pre-market Notification Details

• Device ID: K010212
• 510k Number: K010212
• Device Name: OFFSET TIBIAL TRAY
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
• Applicant: BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Contact: Carol Lauster
• Correspondent: Carol Lauster; BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Product Code: MBV
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-23
• Decision Date: 2001-02-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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