510(k) K232790
- Device
- KONG®-TL VBR System and KONG® C VBR System
- Applicant
- Icotec AG
- 510(k) number
- K232790
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-04
- Date received
- 2023-09-11
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Marina Hess
- Address
- Industriestrasse 12 9450 Altstaetten (Sg) CH
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3014967969
- 2133928
- 3013820501
- 3009241418
- 2530808
- 3006404071
- 3006639944
- 3010197239
- 3039167712
- 2134470
- 1000461041
- 3004464325
- 3014252644
- 3009941480
- 1835831
- 3010041430
- 1000493591
- 3006791286
- 2183946
- 3023852420
- 1834331
- 2032098
- 1824199
- 3015212339
- 3010197224
- 1833920
- 3025603301
- 3003855635
- 3002807112
- 3009760038
- 3005061536
- 2031093
- 3004142400
- 3009504230
- 3011221483
- 1223434
- 2028632
- 9610612
- 1526439
- 3012994232
- 3000170817
- 3014763043
- 3010032903
- 2532027
- 3010120104
- 3005819474
- 3017521423
- 3010162973
- 3006215390
- 3004635447
- 1424434
- 3016443334
- 1222274
- 3014680795
- 3004153896
- 3010041993
- 3005031160
- 3002976036
- 3025602479
- 3010863450
- 3019767615
- 8010099
- 3015831087
- 3016438694
- 3006493760
- 8020776
- 3009973336
- 1043214
- 3010097171
- 3006128100
- 3019837678
- 3002862271
- 9612420
- 3010123256
- 3003935342
- 1649518
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| 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 |
| K183197 | PYRAMESH Implant System | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 |