UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM— 510(k) K943725
Substantially Equivalent for Some IndicationsSynthes Spine
FDA 510(k) clearance K943725 for UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1995-08-25. Applicant: Synthes Spine.
Clearance details
- Applicant
- Synthes Spine
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.