DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Pinnacle With Gription Acetabular Cups.

Pre-market Notification Details

• Device ID: K093646
• 510k Number: K093646
• Device Name: DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
• Classification: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Contact: Rhonda Meyer
• Correspondent: Rhonda Meyer; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988
• Product Code: KWA
• Subsequent Product Code: JDI
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-11-25
• Decision Date: 2009-12-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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