FINN KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

BIOMET, INC.

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

Pre-market Notification Details

• Device ID: K945028
• 510k Number: K945028
• Device Name: FINN KNEE SYSTEM
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Contact: Patricia S Beres
• Correspondent: Patricia S Beres; BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-13
• Decision Date: 1996-02-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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