FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
ORION Spinal System
K Number: K190600
·
Decision Aug 18, 2020
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
1
Review Days
529
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
- ORION Spinal System
- K Number
- K190600
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orion Biotech, Inc.
- Date Received
- March 8, 2019
- Decision Date
- August 18, 2020
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.
Socko Vimax Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ChanPin Pedicle Screw Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Varion Thoracolumbar Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
FDA 510(k)
FDA Class 2
·Orthopedic
AccelFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
PERLA® TL Posterior Thoraco-lumbar Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic