GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID

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 Shoulder Steptech Anchor Peg Glenoid.

Pre-market Notification Details

• Device ID: K092122
• 510k Number: K092122
• Device Name: GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Rhonda Myer
• Correspondent: Rhonda Myer; 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: 2009-07-14
• Decision Date: 2009-07-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295005704	K092122	000
10603295006145	K092122	000
10603295006152	K092122	000
10603295006305	K092122	000
10603295006312	K092122	000
10603295006329	K092122	000
10603295006336	K092122	000
10603295006343	K092122	000
10603295006350	K092122	000
10603295006480	K092122	000
10603295006497	K092122	000
10603295006503	K092122	000
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10603295006527	K092122	000
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10603295006121	K092122	000
10603295005711	K092122	000
10603295005728	K092122	000
10603295005735	K092122	000
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10603295005759	K092122	000
10603295005902	K092122	000
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10603295005940	K092122	000
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10603295006107	K092122	000
10603295006114	K092122	000
10603295006534	K092122	000
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10603295006015	K092122	000
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10603295006190	K092122	000
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10603295006374	K092122	000
10603295006381	K092122	000
10603295006398	K092122	000
10603295006404	K092122	000
10603295005995	K092122	000
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10603295005971	K092122	000
10603295006411	K092122	000