P.F.C. CERAMIC HIP HEAD— 510(k) K962248

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K962248 for P.F.C. CERAMIC HIP HEAD, Substantially Equivalent on 1996-08-29. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 1996-06-11
Decision date: 1996-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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.