ORTHOGENESIS LPS SYSTEM

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

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Orthogenesis Lps System.

Pre-market Notification Details

• Device ID: K003182
• 510k Number: K003182
• Device Name: ORTHOGENESIS LPS SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988
• Contact: Janet G Johnson
• Correspondent: Janet G Johnson; DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 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: 2000-10-11
• Decision Date: 2001-06-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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