OSTEO BONE SCREWS— 510(k) K913269

Substantially Equivalent

Fred C. Bryson

FDA 510(k) clearance K913269 for OSTEO BONE SCREWS, Substantially Equivalent on 1991-11-22. Applicant: Fred C. Bryson.

Clearance details

Applicant: Fred C. Bryson
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1991-07-23
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood, SC, 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.