FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Navigation Module of the Momentum System
K Number: K200845
·
Decision Sep 10, 2020
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
8
Review Days
163
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Basic Information
- Device Name
- Navigation Module of the Momentum System
- K Number
- K200845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulrich Medical USA
- Date Received
- March 31, 2020
- Decision Date
- September 10, 2020
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Ulrich Medical USA
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |