S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD— 510(k) K913231

Substantially Equivalent

Joint Medical Products Corp.

FDA 510(k) clearance K913231 for S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD, Substantially Equivalent on 1991-12-20. Applicant: Joint Medical Products Corp..

Clearance details

Applicant: Joint Medical Products Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1991-07-22
Decision date: 1991-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.