A-CIFT SoloFuse
FDA 510(k) clearance K172484 · decided 2018-05-08
Clearance details
- K-number
- K172484
- Device name
- A-CIFT SoloFuse
- Applicant
- Spinefrontier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-17
- Decision date
- 2018-05-08
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Malden, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.