DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, And Depuy Ultima Unipolar Femoral Heads.

Pre-market Notification Details

• Device ID: K033273
• 510k Number: K033273
• Device Name: DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Natalie Heck
• Correspondent: Natalie Heck; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-10-10
• Decision Date: 2004-05-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295014997	K033273	000
10603295014980	K033273	000
10603295015031	K033273	000
10603295015024	K033273	000
10603295015017	K033273	000
10603295015000	K033273	000
10603295014973	K033273	000
10603295014850	K033273	000
10603295014836	K033273	000