PROSTHESIS, KNEE, TOTAL

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 Prosthesis, Knee, Total.

Pre-market Notification Details

• Device ID: K781294
• 510k Number: K781294
• Device Name: PROSTHESIS, KNEE, TOTAL
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: BIOMET, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-07-27
• Decision Date: 1978-08-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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