PRIMALOC CEMENTLESS HIP SYSTEM— 510(k) K953977

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K953977 for PRIMALOC CEMENTLESS HIP SYSTEM, Substantially Equivalent on 1996-01-26. Applicant: Ortho Development Corp..

Clearance details

Applicant: Ortho Development Corp.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1995-08-23
Decision date: 1996-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.