510(k) K061891
- Device
- SYNEX II
- Applicant
- SYNTHES SPINE CO.LP
- 510(k) number
- K061891
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-18
- Date received
- 2006-07-03
- 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
- BONNIE J SMITH
- Address
- 1302 Wrights Ln. E. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3005677016
- 3005706667
- 3008583793
- 2032093
- 3027201862
- 3010375065
- 2245304
- 3006487372
- 3004638600
- 3010123206
- 3014725904
- 1000493591
- 1834379
- 3012120772
- 3016438694
- 3003761012
- 3030412764
- 3009051471
- 8010099
- 3005144609
- 3003477135
- 1223434
- 2183449
- 3015212339
- 3010041430
- 3007922509
- 3010162973
- 1000200989
- 3008868758
- 3009888740
- 3005751028
- 3010705004
- 2134947
- 3006846753
- 3005031160
- 1226544
- 3009959868
- 3014967969
- 3002976036
- 3003855635
- 3010120104
- 3010123256
- 1530390
- 1000517406
- 3006783837
- 3009973336
- 3007993775
- 3010049501
- 3010160527
- 3013820501
- 1722511
- 1030489
- 3006791286
- 2031966
- 3002862271
- 3007200272
- 2532027
- 3004893332
- 1529009
- 8043792
- 3005819474
- 3004142400
- 1424434
- 3014019090
- 3014680795
- 3003526896
- 3000170817
- 9681642
- 3012329926
- 1450662
- 3006128100
- 1226146
- 2031093
- 1219518
- 3006215390
- 1833986
- 3022159082
- 3010097171
- 3011795235
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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