STAPLE, FIXATION BONE; SCREW FIXATION BONE— 510(k) K931155

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K931155 for STAPLE, FIXATION BONE; SCREW FIXATION BONE, Substantially Equivalent on 1994-09-01. Applicant: Roseburg SA.

Clearance details

Applicant: Roseburg SA
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1993-03-09
Decision date: 1994-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.