510(k) K241895
- Device
- Cannulated PsiFGuard
- Applicant
- Spineguard
- 510(k) number
- K241895
- Product code
- SCY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-26
- Date received
- 2024-06-28
- Regulation
- 888.3040
- Classification name
- Sacroiliac Joint Guidewire Placement Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stephane Bette
- Address
- 10 Cours Louis Lumiere, 4th Floor Vincennes FR 94300 94300
FDA Registration Numbers#
- 3008102049