510(k) K240623
- Device
- Omnia Medical TiBrid?-SA System
- Applicant
- Omnia Medical, LLC
- 510(k) number
- K240623
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-24
- Date received
- 2024-03-05
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Troy Schifano
- Address
- 6 Canyon Rd., Suite 300 Morgantown, WV US 26508 26508
FDA Registration Numbers#
- 3008850074
- 3015869492
- 9616680
- 3008773560
- 2029275
- 3006128100
- 3009962553
- 3006563559
- 2183449
- 9610612
- 3010041499
- 3010197224
- 3026776
- 1835444
- 1423662
- 3013194153
- 3007289746
- 3039167712
- 9611813
- 3003637761
- 1724955
- 3013758617
- 3033509898
- 2648623
- 3008110533
- 3010047454
- 3005178931
- 3009049161
- 3007993775
- 3012711663
- 3015398319
- 1047843
- 3018094310
- 1530390
- 2032521
- 3009973505
- 3010863450
- 3003597504
- 3008868758
- 2028632
- 1928237
- 2532027
- 1424434
- 3014725904
- 3010097171
- 3022295665
- 3013491327
- 2031966
- 3008262872
- 3009144915
- 3009756327
- 3010363503
- 3010531069
- 3009189869
- 3010560653
- 1000432246
- 1824199
- 8043792
- 3010120148
- 1057425
- 3014680795
- 1526439
- 3004024955
- 2531195
- 3000170817
- 1220477
- 3005061536
- 3024999441
- 3009888740
- 3003761012
- 3005144609
- 3008812560
- 3009882675
- 3006783837
- 3008583793
- 3010047402
- 3016112537
- 3016460869
- 3015869493
- 3018210489
Source Documents#
Other 510(k) Records For Product Code OVD#
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|---|---|---|---|
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026-04-29 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 |
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| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 |
| K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2025-03-17 |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-12-13 |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 |