DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS— 510(k) K033273

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K033273 for DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS, Substantially Equivalent on 2004-05-06. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2003-10-10
Decision date: 2004-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.