510(k) K030736
- Device
- VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
- Applicant
- MEDTRONIC SOFAMOR DANEK
- 510(k) number
- K030736
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-02
- Date received
- 2003-03-10
- Regulation
- 888.3060
- Classification name
- Spinal Vertebral Body Replacement Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3015869493
- 1833920
- 3006639944
- 9681642
- 3015941638
- 1000517406
- 3005061536
- 1030489
- 2532027
- 3004188066
- 3006783837
- 3009144915
- 3010047402
- 3005823819
- 3022159082
- 3006215390
- 1835296
- 3014967969
- 3003855635
- 3013422238
- 3003526896
- 1528646
- 3010160527
- 1226544
- 3009417901
- 3010123256
- 3008868758
- 3007200272
- 3003935342
- 3009217531
- 2648623
- 2028632
- 3009973336
- 2134470
- 9617544
- 3006487372
- 2032112
- 3004719693
- 1649518
- 2031093
- 2134285
- 3012994232
- 3010375065
- 3014252644
- 3000270450
- 3010041499
- 1000200989
- 3008114965
- 1000461041
- 3004024955
- 3019767615
- 3006493760
- 3017528621
- 1529009
- 2133928
- 1043214
- 3009380063
- 3019837678
- 2531195
- 1223434
- 3010162973
- 3017521423
- 3010462278
- 3007993775
- 1222274
- 1423662
- 1000493591
- 3004788213
- 3010370500
- 3043543260
- 3014273501
- 2032098
- 3010047454
- 3010560653
- 1060840
- 1219518
- 3008455034
- 3006404071
- 3006791286
- 3010197224
Source Documents#
Other 510(k) Records For Product Code MQP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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