FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
K Number: K160124
·
Decision Apr 4, 2016
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
302
Applicant Total
2
Review Days
75
Basic Information
- Device Name
- LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
- K Number
- K160124
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SpineVision S.A.
- Date Received
- January 20, 2016
- Decision Date
- April 4, 2016
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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Other Clearances by SpineVision S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | May 4, 2016 | Substantially Equivalent |