DEPUY SIGMA TIBIAL INSERTS

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sigma Tibial Inserts.

Pre-market Notification Details

• Device ID: K033272
• 510k Number: K033272
• Device Name: DEPUY SIGMA TIBIAL INSERTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Cheryl K Hastings
• Correspondent: Cheryl K Hastings; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-10-10
• Decision Date: 2004-02-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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