FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
uNion Cervical Plate System
K Number: K150666
·
Decision Jun 22, 2015
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
8
Review Days
98
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Basic Information
- Device Name
- uNion Cervical Plate System
- K Number
- K150666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulrich Medical USA
- Date Received
- March 16, 2015
- Decision Date
- June 22, 2015
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K230614 | Cortium | May 2, 2023 | Substantially Equivalent |
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| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | Aug 19, 2022 | Substantially Equivalent |
| 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 |