CORTICAL BONE SCREW (EUROPEAN STYLE)— 510(k) K905357

Substantially Equivalent for Some Indications

O'Tec Corp.

FDA 510(k) clearance K905357 for CORTICAL BONE SCREW (EUROPEAN STYLE), Substantially Equivalent for Some Indications on 1991-01-04. Applicant: O'Tec Corp..

Clearance details

Applicant: O'Tec Corp.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1990-11-28
Decision date: 1991-01-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

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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.