FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Idys TLIF TiVac
K Number: K183259
·
Decision Mar 1, 2019
Classifications
1
FEI Numbers
422
Registration Numbers
422
Same Product Code
869
Applicant Total
2
Review Days
100
Basic Information
- Device Name
- Idys TLIF TiVac
- K Number
- K183259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clariance SAS
- Date Received
- November 21, 2018
- Decision Date
- March 1, 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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Other Clearances by Clariance SAS
| K Number | Device Name | ||
|---|---|---|---|
| K191263 | Idys ALIF TiVac | Jun 6, 2019 | Substantially Equivalent |