CAPTIVA SPINE FUSELOX CERVICAL CAGE
FDA 510(k) clearance K110585 · decided 2011-03-25
Clearance details
- K-number
- K110585
- Device name
- CAPTIVA SPINE FUSELOX CERVICAL CAGE
- Applicant
- Captiva Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-01
- Decision date
- 2011-03-25
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- ODP
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sunrise, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.