STALIF X
FDA 510(k) clearance K130461 · decided 2013-08-28
Clearance details
- K-number
- K130461
- Device name
- STALIF X
- Applicant
- Centinel Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-22
- Decision date
- 2013-08-28
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.