FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Idys ALIF 3DTi
K Number: K200919
·
Decision Apr 12, 2021
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
10
Review Days
371
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Basic Information
- Device Name
- Idys ALIF 3DTi
- K Number
- K200919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clariance
- Date Received
- April 6, 2020
- Decision Date
- April 12, 2021
- 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
| K Number | Device Name | ||
|---|---|---|---|
| K243904 | Elegance® Anterior Cervical plate | Jan 14, 2025 | Substantially Equivalent |
| K243670 | Idys® LIF | Dec 31, 2024 | Substantially Equivalent |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Jul 24, 2024 | Substantially Equivalent |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Apr 26, 2024 | Substantially Equivalent |
| K240715 | Idys® C ZP 3DTi | Mar 22, 2024 | Substantially Equivalent |
| K220182 | Aggeris-C | Mar 30, 2022 | Substantially Equivalent |
| K130853 | IDYS(TM) C | Nov 13, 2013 | Substantially Equivalent |
| K131178 | IDYS LIF CAGES | Oct 10, 2013 | Substantially Equivalent |
| K120469 | ERISMA-LP | Aug 13, 2012 | Substantially Equivalent |