FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Virage® OCT Spinal Fixation System
K Number: K250332
·
Decision Apr 4, 2025
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
2
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Virage® OCT Spinal Fixation System
- K Number
- K250332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Highridge Medical, LLC
- Date Received
- February 5, 2025
- Decision Date
- April 4, 2025
- Product Code
- NKG
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKG), ordered by most recent decision date.
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Infinity OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
CMORE® CT System; CMORE® CT System Navigated Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
Infinity OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Highridge Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K253093 | Vital Spinal Fixation System | Dec 17, 2025 | Substantially Equivalent |