FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
icotec Interbody Cage System
K Number: K172480
·
Decision May 17, 2018
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
16
Review Days
274
Basic Information
- Device Name
- icotec Interbody Cage System
- K Number
- K172480
- 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
- August 16, 2017
- Decision Date
- May 17, 2018
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K233215 | icotec Anterior Cervical Plate System | May 17, 2024 | Substantially Equivalent |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Apr 5, 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 |