S-ROM/NOILES MARK 3— 510(k) K896048

Substantially Equivalent

Joint Medical Products Corp.

FDA 510(k) clearance K896048 for S-ROM/NOILES MARK 3, Substantially Equivalent on 1990-03-14. Applicant: Joint Medical Products Corp..

Clearance details

Applicant: Joint Medical Products Corp.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 1989-10-18
Decision date: 1990-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

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Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.