FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
K Number: K243659
·
Decision Apr 2, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
66
Review Days
126
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Basic Information
- Device Name
- FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
- K Number
- K243659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SeaSpine Orthopedics Corporation
- Date Received
- November 27, 2024
- Decision Date
- April 2, 2025
- Product Code
- OLO
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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