DEPUY RECLAIM REVISION HIP SYSTEM

Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

DEPUY (IRELAND)

The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Reclaim Revision Hip System.

Pre-market Notification Details

• Device ID: K102080
• 510k Number: K102080
• Device Name: DEPUY RECLAIM REVISION HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: DEPUY (IRELAND) 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582
• Contact: Rhonda Myer
• Correspondent: Rhonda Myer; DEPUY (IRELAND) 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582
• Product Code: KWA
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-26
• Decision Date: 2010-11-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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