FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
KONG-TL VBR System, KONG-C VBR System
K Number: K200235
·
Decision May 29, 2020
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
16
Review Days
120
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Basic Information
- Device Name
- KONG-TL VBR System, KONG-C VBR System
- K Number
- K200235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icotec AG
- Date Received
- January 30, 2020
- Decision Date
- May 29, 2020
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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| 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 |
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| K201587 | icotec Anterior Cervical Plate System | Oct 15, 2020 | Substantially Equivalent |
| K200596 | G21 Cement, VADER® Pedicle System | Oct 13, 2020 | Substantially Equivalent |