FREEMAN MODULAR HIP STEM RIDGED VERSION— 510(k) K890498

Substantially Equivalent for Some Indications

Orthopedic Systems, Inc.

FDA 510(k) clearance K890498 for FREEMAN MODULAR HIP STEM RIDGED VERSION, Substantially Equivalent for Some Indications on 1989-10-13. Applicant: Orthopedic Systems, Inc..

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1989-02-01
Decision date: 1989-10-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hayward, CA, 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.