Cannulated PsiFGuard
FDA 510(k) clearance K241895 · decided 2024-09-26
Clearance details
- K-number
- K241895
- Device name
- Cannulated PsiFGuard
- Applicant
- Spineguard
- Decision
- Substantially Equivalent
- Date received
- 2024-06-28
- Decision date
- 2024-09-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- SCY
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vincennes, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.