S-ROM TOTAL HIP REPLACEMENT SYSTEM— 510(k) K935078

Substantially Equivalent for Some Indications

Joint Medical Products Corp.

FDA 510(k) clearance K935078 for S-ROM TOTAL HIP REPLACEMENT SYSTEM, Substantially Equivalent for Some Indications on 1994-03-09. Applicant: Joint Medical Products Corp..

Clearance details

Applicant: Joint Medical Products Corp.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1993-10-25
Decision date: 1994-03-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.