NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM— 510(k) K101254
Substantially EquivalentTecnologia Y Diseno Industrial, S.A DE C.V
FDA 510(k) clearance K101254 for NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM, Substantially Equivalent on 2010-07-15. Applicant: Tecnologia Y Diseno Industrial, S.A DE C.V.
Clearance details
- Applicant
- Tecnologia Y Diseno Industrial, S.A DE C.V
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Lyon, MI, 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.