FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
K Number: K232792
·
Decision Apr 5, 2024
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
16
Review Days
207
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Basic Information
- Device Name
- icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- K Number
- K232792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icotec AG
- Date Received
- September 11, 2023
- Decision Date
- April 5, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
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Ventana® P/T Lumbar Interbody System
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aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Icotec AG
| K Number | Device Name | ||
|---|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Nov 12, 2025 | Substantially Equivalent |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | Feb 27, 2025 | Substantially Equivalent |
| K233215 | icotec Anterior Cervical Plate System | May 17, 2024 | Substantially Equivalent |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Apr 4, 2024 | Substantially Equivalent |
| K232628 | VADER® Pedicle System | Feb 26, 2024 | Substantially Equivalent |
| K230861 | VADER® Pedicle System Navigated Instruments | Jun 27, 2023 | Substantially Equivalent |
| K222789 | VADER® Pedicle System, G21 Cement | Jan 9, 2023 | Substantially Equivalent |
| K201587 | icotec Anterior Cervical Plate System | Oct 15, 2020 | Substantially Equivalent |
| K200596 | G21 Cement, VADER® Pedicle System | Oct 13, 2020 | Substantially Equivalent |
| K200235 | KONG-TL VBR System, KONG-C VBR System | May 29, 2020 | Substantially Equivalent |