LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Lps Universal Tibial Hinge Inserts, Model 198727012-198727331.

Pre-market Notification Details

• Device ID: K091453
• 510k Number: K091453
• Device Name: LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Suzana Otano
• Correspondent: Suzana Otano; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-18
• Decision Date: 2009-08-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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