TRUE/FLEX TIBIAL RODS WITH CAP— 510(k) K912710

Substantially Equivalent

Applied Osteo Systems, Inc.

FDA 510(k) clearance K912710 for TRUE/FLEX TIBIAL RODS WITH CAP, Substantially Equivalent on 1991-10-15. Applicant: Applied Osteo Systems, Inc..

Clearance details

Applicant: Applied Osteo Systems, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1991-06-19
Decision date: 1991-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.