FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpineAR SNAP (SyncAR Spine)
K Number: K252054
·
Decision Sep 29, 2025
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
41
Applicant Total
4
Review Days
90
Basic Information
- Device Name
- SpineAR SNAP (SyncAR Spine)
- K Number
- K252054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Theater, Inc.
- Date Received
- July 1, 2025
- Decision Date
- September 29, 2025
- Product Code
- SBF
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SBF | Orthopedic Augmented Reality | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SBF), ordered by most recent decision date.
Knee+
FDA 510(k)
FDA Class 2
·Neurology
NextAR Hip Platform
FDA 510(k)
FDA Class 2
·Neurology
xvision Spine system
FDA 510(k)
FDA Class 2
·Neurology
OptiVu Shoulder
FDA 510(k)
FDA Class 2
·Neurology
NextAR(TM) Shoulder Platform
FDA 510(k)
FDA Class 2
·Neurology
OptiVu Shoulder
FDA 510(k)
FDA Class 2
·Neurology