ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT

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

INSTRUMENT MAKAR, INC.

The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for St Leger Cemented Semi-constrained Total Knee Implant.

Pre-market Notification Details

• Device ID: K980999
• 510k Number: K980999
• Device Name: ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864
• Contact: Lanny J Johnson
• Correspondent: Lanny J Johnson; INSTRUMENT MAKAR, INC. 2950 EAST MT. HOPE RD. Okemos, MI 48864
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-18
• Decision Date: 1998-11-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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