TIBIA ORTHONAIL— 510(k) K955761

Substantially Equivalent

Orthologic Corp.

FDA 510(k) clearance K955761 for TIBIA ORTHONAIL, Substantially Equivalent on 1996-03-13. Applicant: Orthologic Corp..

Clearance details

Applicant: Orthologic Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1995-12-18
Decision date: 1996-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, 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.