FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
uCerv Flux-C 3D Porous Titanium Cervical Interbody
K Number: K220696
·
Decision Aug 19, 2022
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
8
Review Days
163
Basic Information
- Device Name
- uCerv Flux-C 3D Porous Titanium Cervical Interbody
- K Number
- K220696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulrich Medical USA
- Date Received
- March 9, 2022
- Decision Date
- August 19, 2022
- 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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| K200845 | Navigation Module of the Momentum System | Sep 10, 2020 | Substantially Equivalent |
| K191932 | Momentum Posterior Spinal Fixation System | Oct 2, 2019 | Substantially Equivalent |
| K181921 | Solidity Vertebral Body Replacement | Nov 16, 2018 | Substantially Equivalent |
| K150666 | uNion Cervical Plate System | Jun 22, 2015 | Substantially Equivalent |