FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solidity Vertebral Body Replacement
K Number: K181921
·
Decision Nov 16, 2018
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
8
Review Days
121
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Basic Information
- Device Name
- Solidity Vertebral Body Replacement
- K Number
- K181921
- 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
- July 18, 2018
- Decision Date
- November 16, 2018
- 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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Other Clearances by Ulrich Medical USA
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|---|---|---|---|
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | Oct 20, 2023 | Substantially Equivalent |
| K230614 | Cortium | May 2, 2023 | Substantially Equivalent |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | Nov 28, 2022 | Substantially Equivalent |
| 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 |
| K150666 | uNion Cervical Plate System | Jun 22, 2015 | Substantially Equivalent |