FDA 510(k) K093646, DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS, by DePuy Orthopaedics, Inc.
FDA 510(k) K093646, DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS, by DePuy Orthopaedics, Inc.
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number: K093646
Device Name: DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
Applicant: DePuy Orthopaedics, Inc.
Regulation Number: 888.335
Classification Product Code: JDI
Date Received: 2009-11-25
Decision Date: 2009-12-17
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 1,371
Fully redacted pages: 342
Content pages: 1,029
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