ORTHOLOC(TM) BONE SCREWS— 510(k) K112772

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K112772 for ORTHOLOC(TM) BONE SCREWS, Substantially Equivalent on 2011-10-07. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2011-09-23
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Arlington, TN, 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.