NORTHO BONE SCREW— 510(k) K925872

Substantially Equivalent for Some Indications

Northo Orthopedics

FDA 510(k) clearance K925872 for NORTHO BONE SCREW, Substantially Equivalent for Some Indications on 1996-03-22. Applicant: Northo Orthopedics.

Clearance details

Applicant: Northo Orthopedics
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1992-11-19
Decision date: 1996-03-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Las Cruces, NM, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.