I.B.S. 2.0 Osteosynthesis screw— 510(k) K160174

Substantially Equivalent

In2bones Sas

FDA 510(k) clearance K160174 for I.B.S. 2.0 Osteosynthesis screw, Substantially Equivalent on 2016-10-06. Applicant: In2bones Sas.

Clearance details

Applicant: In2bones Sas
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2016-01-27
Decision date: 2016-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ecully, FR

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.