DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Global C.ap. Cta Resurfacing Shoulder.

Pre-market Notification Details

• Device ID: K080990
• 510k Number: K080990
• Device Name: DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
• Classification: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Dawn Sinclair
• Correspondent: Dawn Sinclair; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: HSD
• CFR Regulation Number: 888.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-07
• Decision Date: 2008-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295018100	K080990	000
10603295018025	K080990	000
10603295018032	K080990	000
10603295018049	K080990	000
10603295018056	K080990	000
10603295018063	K080990	000
10603295018070	K080990	000
10603295018087	K080990	000
10603295018094	K080990	000
10603295018018	K080990	000