FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Idys ALIF ZP 3DTi
K Number: K192168
·
Decision Nov 4, 2019
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
11
Review Days
87
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Basic Information
- Device Name
- Idys ALIF ZP 3DTi
- K Number
- K192168
- 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
- August 9, 2019
- Decision Date
- November 4, 2019
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Clariance, Sas
| K Number | Device Name | ||
|---|---|---|---|
| K202032 | Idys LLIF 3DTi | Apr 1, 2021 | Substantially Equivalent |
| K202956 | Erisma LP Navigated Instruments | Feb 26, 2021 | Substantially Equivalent |
| K200920 | Idys ALIF ZP 3DTi | May 29, 2020 | Substantially Equivalent |
| K191263 | Idys ALIF TiVac | Jun 6, 2019 | Substantially Equivalent |
| K183259 | Idys TLIF TiVac | Mar 1, 2019 | Substantially Equivalent |
| K172465 | Idys TLIF 3DTi Cages | Dec 15, 2017 | Substantially Equivalent |
| K172083 | Idys ALIF System | Nov 8, 2017 | Substantially Equivalent |
| K170163 | Erisma® LP Spinal Fixation System | Feb 14, 2017 | Substantially Equivalent |
| K162367 | Erisma® LP MIS | Oct 27, 2016 | Substantially Equivalent |
| K153326 | Erisma-LP Spinal Fixation System | Mar 8, 2016 | Substantially Equivalent |