GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head.

Pre-market Notification Details

• Device ID: K992065
• 510k Number: K992065
• Device Name: GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Janet Johnson
• Correspondent: Janet Johnson; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-18
• Decision Date: 1999-07-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295005285	K992065	000
10603295005278	K992065	000
10603295005230	K992065	000
10603295005223	K992065	000
10603295005186	K992065	000
10603295005179	K992065	000
10603295005131	K992065	000
10603295005124	K992065	000