FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
VADER® Pedicle System, G21 Cement
K Number: K222789
·
Decision Jan 9, 2023
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
18
Applicant Total
16
Review Days
116
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Basic Information
- Device Name
- VADER® Pedicle System, G21 Cement
- K Number
- K222789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icotec AG
- Date Received
- September 15, 2022
- Decision Date
- January 9, 2023
- Product Code
- PML
- 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 |
|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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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 |
| 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 |
| 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 |