FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
K Number: K231809
·
Decision Oct 20, 2023
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
18
Applicant Total
8
Review Days
122
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
- K Number
- K231809
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ulrich Medical USA
- Date Received
- June 20, 2023
- Decision Date
- October 20, 2023
- Product Code
- PML
- 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 |
|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PML), ordered by most recent decision date.
Dynamo Spinal Cement; Salvo® Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
PERLA® TL System; TEKTONA® HV US Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
VADER® Pedicle System, G21 Cement
FDA 510(k)
FDA Class 2
·Orthopedic
Invictus® Bone Cement, Invictus Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Ulrich Medical USA
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K181921 | Solidity Vertebral Body Replacement | Nov 16, 2018 | Substantially Equivalent |
| K150666 | uNion Cervical Plate System | Jun 22, 2015 | Substantially Equivalent |