DEPUT DELTA XTEND REVERSE SHOULDER

Shoulder Prosthesis, Reverse Configuration

DEPUY FRANCE

The following data is part of a premarket notification filed by Depuy France with the FDA for Deput Delta Xtend Reverse Shoulder.

Pre-market Notification Details

• Device ID: K120174
• 510k Number: K120174
• Device Name: DEPUT DELTA XTEND REVERSE SHOULDER
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: DEPUY FRANCE 700 ORTHOPAEDIC DRIVE Warsaw, IN 46580
• Contact: Megan Burns
• Correspondent: Megan Burns; DEPUY FRANCE 700 ORTHOPAEDIC DRIVE Warsaw, IN 46580
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-20
• Decision Date: 2012-06-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295423652	K120174	000
10603295423645	K120174	000
10603295272915	K120174	000
10603295272908	K120174	000