VISUALIF CHALLENGING ACCESS PLATE
FDA 510(k) clearance K122168 · decided 2012-10-11
Clearance details
- K-number
- K122168
- Device name
- VISUALIF CHALLENGING ACCESS PLATE
- Applicant
- Spine Smith Partners L.P.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-23
- Decision date
- 2012-10-11
- Days to decision
- 80 days
- Clearance type
- Special
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.