FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
K Number: K190193
·
Decision Mar 4, 2019
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
- K Number
- K190193
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineex, Inc.
- Date Received
- February 4, 2019
- Decision Date
- March 4, 2019
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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