DEPUY PINNACLE 100 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 100 With Gription Acetabular Cups.

Pre-market Notification Details

• Device ID: K090998
• 510k Number: K090998
• Device Name: DEPUY PINNACLE 100 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 Myer
• Correspondent: Rhonda Myer; 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: 2009-04-08
• Decision Date: 2009-06-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295010272	K090998	000
10603295010173	K090998	000
10603295010180	K090998	000
10603295010197	K090998	000
10603295010203	K090998	000
10603295010210	K090998	000
10603295010227	K090998	000
10603295010234	K090998	000
10603295010241	K090998	000
10603295010258	K090998	000
10603295010265	K090998	000
10603295010166	K090998	000