S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP— 510(k) K851422

Substantially Equivalent

Joint Medical Products Corp.

FDA 510(k) clearance K851422 for S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP, Substantially Equivalent on 1985-09-18. Applicant: Joint Medical Products Corp..

Clearance details

Applicant: Joint Medical Products Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1985-04-10
Decision date: 1985-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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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.