INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Insall/burstein Fiber Metal Condylar/kne.

Pre-market Notification Details

• Device ID: K830121
• 510k Number: K830121
• Device Name: INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-01-11
• Decision Date: 1983-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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