OSTEONICS(R) 6011 HIP STEM SERIES— 510(k) K905158

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K905158 for OSTEONICS(R) 6011 HIP STEM SERIES, Substantially Equivalent for Some Indications on 1991-01-04. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1990-11-16
Decision date: 1991-01-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, NJ, 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.