AGC REVISION KNEE PROTHESIS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

BIOMET, INC.

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

Pre-market Notification Details

• Device ID: K912245
• 510k Number: K912245
• Device Name: AGC REVISION KNEE PROTHESIS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587
• Contact: Patricia M Sandborn
• Correspondent: Patricia M Sandborn; BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-05-21
• Decision Date: 1991-08-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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