510(k) K180665
- Device
- SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
- Applicant
- K2M, LLC.
- 510(k) number
- K180665
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-28
- Date received
- 2018-03-14
- 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
- Nancy Giezen
- Address
- 600 Hope Pkwy. SE Leesburg VA US 20175 20175
FDA Registration Numbers#
- 1834331
- 3010462278
- 3010863450
- 3041915189
- 3002976036
- 3004188066
- 3010009693
- 1526534
- 3009760038
- 3016438694
- 1720929
- 2245304
- 3004788213
- 3018094310
- 3004638600
- 3008534770
- 3012447612
- 3014763043
- 3006846753
- 3005677016
- 1828464
- 3003120897
- 1722511
- 3010041993
- 3003935342
- 2530808
- 1835296
- 3003477135
- 2532027
- 8010099
- 8010944
- 3011577940
- 3010363503
- 3004893332
- 1057425
- 3006487372
- 3009144915
- 3003526896
- 3004153896
- 9681642
- 1833920
- 3005031160
- 3011683674
- 3005497913
- 3010041430
- 3006215390
- 3009957608
- 3016050940
- 1526439
- 3006639944
- 3015869493
- 3005076207
- 3009241418
- 9615128
- 2028632
- 3009417901
- 1649518
- 1000493591
- 1424263
- 3009051471
- 2032093
- 1424434
- 3003597504
- 3013820501
- 3004635447
- 9610612
- 3009887475
- 2032098
- 3010197224
- 3005144609
- 3005061536
- 2134285
- 1000461041
- 3010032903
- 1643817
- 3006783837
- 3036756245
- 3005823819
- 3008583793
- 2134947
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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