CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
FDA 510(k) clearance K160879 · decided 2016-12-20
Clearance details
- K-number
- K160879
- Device name
- CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems
- Applicant
- Medos International Sàrl
- Decision
- Substantially Equivalent
- Date received
- 2016-03-30
- Decision date
- 2016-12-20
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- PML
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lelocle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.