510(k) K231134
- Device
- VerteLoc Spinal System
- Applicant
- Signature Orthopaedics Pty, Ltd.
- 510(k) number
- K231134
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-13
- Date received
- 2023-04-21
- Regulation
- 888.3060
- Classification name
- Spinal Vertebral Body Replacement Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Declan Brazil
- Address
- 7 Sirius Rd. Lane Cove West AU 2066 2066
FDA Registration Numbers#
- 3015869492
- 3027201862
- 8010944
- 3006128100
- 2029275
- 3014019090
- 3007200272
- 2183449
- 9610612
- 3010041499
- 3014763043
- 3010197224
- 9615021
- 1219518
- 1835444
- 1423662
- 3039167712
- 9611813
- 3009957608
- 3033509898
- 2648623
- 3010041993
- 3009760038
- 3010047454
- 3007993775
- 3002976036
- 2032112
- 1530390
- 3018094310
- 3011221483
- 3009973505
- 3010863450
- 3003597504
- 3008868758
- 2028632
- 2245304
- 2532027
- 1424434
- 3014725904
- 3010097171
- 3005823819
- 3013491327
- 2031966
- 3008262872
- 3009144915
- 3010363503
- 3010560653
- 1824199
- 8043792
- 3014680795
- 1057425
- 1526439
- 2531195
- 1836357
- 3004024955
- 3000170817
- 1220477
- 3005061536
- 1528646
- 3009888740
- 3003761012
- 3005144609
- 3008812560
- 3009882675
- 3006783837
- 3008583793
- 3010047402
- 3015869493
- 3005819474
- 3010160527
- 1000461041
- 3017528621
- 3005031160
- 3000270450
- 3010375065
- 8020776
- 3005032068
- 1060840
- 3009417901
Source Documents#
Other 510(k) Records For Product Code MQP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253158 | VyBrate™ VBR System | Vy Spine, LLC | 2026-01-07 |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024-11-07 |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024-04-04 |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024-03-08 |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023-10-06 |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | 2022-10-06 |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020-12-23 |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020-05-29 |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2020-02-26 |
| K192117 | Small VBR™ | Ulrich GmbH & Co. KG | 2019-11-01 |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | 2019-10-24 |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | 2019-10-11 |
| K183054 | SYNMESH System | Depuy Synthes Spine | 2019-05-23 |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | 2019-05-08 |
| K183197 | PYRAMESH™ Implant System | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 |