WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW— 510(k) K961157
Substantially Equivalent for Some IndicationsWhiteside Biomechanics, Inc.
FDA 510(k) clearance K961157 for WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW, Substantially Equivalent for Some Indications on 1996-05-17. Applicant: Whiteside Biomechanics, Inc..
Clearance details
- Applicant
- Whiteside Biomechanics, Inc.
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Creve Coeur, MO, US
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, through . 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.