DEPUY MODULAR M 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 Modular M Heads.

Pre-market Notification Details

• Device ID: K060031
• 510k Number: K060031
• Device Name: DEPUY MODULAR M HEADS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46580
• Contact: Keli K Hankee
• Correspondent: Keli K Hankee; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46580
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-05
• Decision Date: 2006-01-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295034407	K060031	000
10603295034070	K060031	000
10603295034056	K060031	000
10603295034032	K060031	000
10603295034018	K060031	000
10603295033875	K060031	000
10603295033851	K060031	000
10603295033790	K060031	000
10603295033776	K060031	000
10603295033752	K060031	000
10603295033738	K060031	000
10603295033042	K060031	000
10603295033028	K060031	000
10603295033004	K060031	000
10603295032984	K060031	000
10603295032960	K060031	000
10603295034094	K060031	000
10603295034117	K060031	000
10603295034131	K060031	000
10603295034391	K060031	000
10603295034384	K060031	000
10603295034377	K060031	000
10603295034360	K060031	000
10603295034308	K060031	000
10603295034292	K060031	000
10603295034285	K060031	000
10603295034278	K060031	000
10603295034261	K060031	000
10603295034254	K060031	000
10603295034230	K060031	000
10603295034216	K060031	000
10603295034193	K060031	000
10603295034179	K060031	000
10603295034155	K060031	000
10603295032946	K060031	000