CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM— 510(k) K133205
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K133205 for CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM, Substantially Equivalent on 2014-03-13. Applicant: Medtronic Sofamor Danek USA, Inc..
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Code MAX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.