510(k) K211892
- Device
- ArtFx Corpectomy Cages (Espinax And Distractania Corpectomy Cages)
- Applicant
- ARFTX Medical LLC
- 510(k) number
- K211892
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-06
- Date received
- 2021-06-21
- 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
- Ozgen Ozfidan
- Address
- 50 Laura St. #2524 Jacksonville FL US 32202 32202
FDA Registration Numbers#
- 1000517406
- 1000200989
- 3003526896
- 3009241418
- 3027201862
- 3015831087
- 3010041430
- 3002807112
- 3010560653
- 3015212339
- 3006846753
- 3009957608
- 3005076207
- 1057425
- 3010047454
- 3003597504
- 3005031160
- 2134947
- 3015542154
- 3014725904
- 3010120104
- 1030489
- 3015440604
- 9681642
- 2531195
- 3036756245
- 1835572
- 3002976036
- 2648623
- 2134470
- 3014680795
- 1226544
- 3004142400
- 8020776
- 3013820501
- 2245304
- 3010363503
- 3010160527
- 3004774118
- 1834331
- 1834379
- 3002862271
- 3043543260
- 3004638532
- 9611813
- 3009051471
- 1220477
- 2028632
- 1000493591
- 3014019090
- 3000270450
- 3004024955
- 3009144915
- 3011795235
- 2183946
- 3017521423
- 3008455034
- 3005677016
- 1835444
- 3010863450
- 2032098
- 1000461041
- 3005706667
- 1043214
- 3008262872
- 3009887475
- 3004188066
- 2134285
- 3009888740
- 3011683674
- 3014273501
- 3009882462
- 3015876273
- 2032093
- 3009959868
- 3009973336
- 3019878714
- 3013491327
- 3004464325
- 1424434
Source Documents#
Other 510(k) Records For Product Code MQP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026-07-31 |
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | 2026-07-10 |
| 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 |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | 2024-02-13 |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023-10-06 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases