FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MagnetOs Flex Matrix
K Number: K213959
·
Decision Apr 14, 2022
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
12
Review Days
118
Basic Information
- Device Name
- MagnetOs Flex Matrix
- K Number
- K213959
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kuros Biosciences B.V
- Date Received
- December 17, 2021
- Decision Date
- April 14, 2022
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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Other Clearances by Kuros Biosciences B.V
| K Number | Device Name | ||
|---|---|---|---|
| K243474 | MagnetOs MIS | May 23, 2025 | Substantially Equivalent |
| K240442 | MagnetOs Putty | Apr 1, 2024 | Substantially Equivalent |
| K232347 | MagnetOs Granules | Jan 19, 2024 | Substantially Equivalent |
| K230736 | MagnetOs Putty | Dec 20, 2023 | Substantially Equivalent |
| K233607 | MagnetOs Easypack Putty | Dec 15, 2023 | Substantially Equivalent |
| K233245 | MagnetOs Flex Matrix | Nov 21, 2023 | Substantially Equivalent |
| K213111 | MagnetOs granules | Jan 10, 2022 | Substantially Equivalent |
| K211201 | MagnetOs Easypack Putty | Sep 2, 2021 | Substantially Equivalent |
| K183092 | Kuros TLIF Cage | Mar 8, 2019 | Substantially Equivalent |
| K181958 | MagnetOs Putty | Dec 6, 2018 | Substantially Equivalent |