510(k) K231809
- Device
- Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
- Applicant
- Ulrich Medical USA
- 510(k) number
- K231809
- Product code
- PML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-20
- Date received
- 2023-06-20
- Regulation
- 888.3027
- Classification name
- Bone Cement, Posterior Screw Augmentation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Eric Lucas
- Address
- 3700 E Plano Pkwy. Suite 200 Plano TX US 75074 75074
FDA Registration Numbers
- 3005180920
- 3006639944
- 3010041430
- 3006791286
- 3023852420
- 1834331
- 1824199
- 3017155536
- 1833920
- 3008572623
- 3008132398
- 3004142400
- 1526439
- 3010032903
- 3015219237
- 3010120104
- 9612277
- 9611390
- 3019767615
- 3015831087
- 3016438694
- 3006493760
- 3008110533
- 3006128100
- 3005739886
- 3003935342
- 1649518
- 9681465
- 1030489
- 3030412764
- 2031966
- 9617616
- 1526534
- 1835251
- 1056553
- 3003120897
- 2647346
- 2648623
- 3037407500
- 3040335671
- 3005497913
- 1224360
- 3013546462
- 3043543260
- 2027467
- 9615014
- 3015941638
- 3009973505
- 9614841
- 3014003062
- 1221763
- 3006017180
- 9610726
- 3014725904
- 2029275
- 1226544
- 3008114965
- 9615128
- 3010049501
- 3008868758
- 3005677016
- 3007993775
- 3009050824
- 3019878714
- 3006783837
- 3002806603
- 3015869493
- 3007441485
- 3015967359
- 3009144915
- 8043792
- 3003761012
- 3010363503
- 1424263
- 3007014520
- 3018094310
- 3007728266
- 3009959868
- 2648666
- 3005823819
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code PML
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2026-01-22 |
| K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | 2024-06-12 |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart | 2023-06-23 |
| K222789 | VADER® Pedicle System, G21 Cement | Icotec AG | 2023-01-09 |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022-12-20 |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2022-08-26 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021-10-28 |
| K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020-10-13 |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | Medtronic | 2020-08-19 |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | 2020-03-31 |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics , Ltd. | 2019-09-19 |
| K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2019-09-12 |
| K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018-11-28 |
| K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System | Globus Medical, Inc. | 2018-03-27 |
| K171938 | KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set | Medtronic | 2017-10-23 |