510(k) K142150
- Device
- AIS MODULIFT VBR SYSTEM
- Applicant
- AESCULAP IMPLANT SYSTEM, INC.
- 510(k) number
- K142150
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-10-29
- Date received
- 2014-08-05
- 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
- LISA M BOYLE
- Address
- 3773 Corporate Pkwy. Center Valley PA US 18034 18034
FDA Registration Numbers#
- 3010097171
- 3041915189
- 3004638532
- 2031966
- 1424263
- 3014273501
- 3003761012
- 3010160527
- 3005076207
- 9615021
- 3015869492
- 3010560653
- 3012447612
- 1935627
- 3011577940
- 3015207155
- 1000493591
- 3043543260
- 3006791286
- 3015440604
- 3007922509
- 3014252644
- 3010120104
- 3010041430
- 3002807112
- 3017521423
- 3019837678
- 3013491327
- 1057425
- 1722511
- 3005823819
- 2532027
- 2183449
- 3009144915
- 3014680795
- 1219518
- 1043214
- 3010370500
- 3004188066
- 3006215390
- 1833920
- 2183946
- 1000200989
- 1835296
- 3009760038
- 3010197224
- 2028632
- 1528646
- 3005144609
- 3006217744
- 3010375065
- 2032098
- 3008868758
- 3009217531
- 3022159082
- 3015542154
- 1030489
- 8020776
- 3012329926
- 3002976036
- 1835572
- 3025603301
- 3011221483
- 3007993775
- 3011795235
- 3005819474
- 1000517406
- 3014763043
- 1526534
- 3004635447
- 3009887475
- 3004024955
- 3010047454
- 3019767615
- 3005677016
- 3003387384
- 3003935342
- 3008114965
- 3009051471
- 3017528621
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 |
| 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 |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | 2019-05-08 |
Legacy Summary#
summary
FDA Review#
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