510(k) K052384
- Device
- LANX VBR SYSTEM
- Applicant
- LANX, LLC
- 510(k) number
- K052384
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-07
- Date received
- 2005-08-30
- 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
- DAVID W SCHLERF
- Address
- 200 Gregory Ln. Suite C-100 Pleasant Hill CA US 94523 94523
FDA Registration Numbers#
- 1649518
- 3010197239
- 3010370500
- 1529009
- 2531195
- 3009144915
- 3005497913
- 3009957608
- 2028632
- 3043543260
- 3004188066
- 3007200272
- 3010560653
- 3006783837
- 3002862271
- 9615766
- 3008583793
- 3006791286
- 8020776
- 3009380063
- 2245304
- 3004719693
- 1528646
- 1835831
- 1834379
- 3010162973
- 3015179588
- 3030412764
- 3019837678
- 3010363503
- 3025603301
- 2531477
- 3006487372
- 3012120772
- 3030183061
- 3017521423
- 3006215390
- 3004638532
- 3009882675
- 1833986
- 3010120135
- 2530808
- 1835296
- 3006128100
- 3005751028
- 2031966
- 3014725904
- 3003120897
- 3006846753
- 3009959868
- 3012994232
- 3009941480
- 3041915189
- 3005823819
- 3003387384
- 3009760038
- 3017528621
- 3010120104
- 3015207155
- 3005677016
- 3025457095
- 3003935342
- 3009217531
- 3011221483
- 1000517406
- 1000461041
- 3010041499
- 3019767615
- 9611813
- 1043214
- 3010049501
- 3010462278
- 3015542154
- 3009051471
- 3010032903
- 3004142400
- 3003526896
- 3009973505
- 3010120326
- 3015941638
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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