P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR— 510(k) K930712

Substantially Equivalent

Johnson & Johnson Orthopaedics, Inc.

FDA 510(k) clearance K930712 for P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR, Substantially Equivalent on 1993-10-04. Applicant: Johnson & Johnson Orthopaedics, Inc..

Clearance details

Applicant: Johnson & Johnson Orthopaedics, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1993-02-11
Decision date: 1993-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.