CUVIS-spine
FDA 510(k) clearance K222698 · decided 2022-10-07
Clearance details
- K-number
- K222698
- Device name
- CUVIS-spine
- Applicant
- Curexo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-07
- Decision date
- 2022-10-07
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.