VAULT ALIF SYSTEM
FDA 510(k) clearance K103369 · decided 2011-04-04
Clearance details
- K-number
- K103369
- Device name
- VAULT ALIF SYSTEM
- Applicant
- Spinal USA
- Decision
- Substantially Equivalent
- Date received
- 2010-11-17
- Decision date
- 2011-04-04
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Pear, MS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.