510(k) K183054
- Device
- SYNMESH System
- Applicant
- DePuy Synthes Spine
- 510(k) number
- K183054
- Product code
- MQP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-23
- Date received
- 2018-11-02
- 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
- Michelle Hughes
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 1000493591
- 3009380063
- 3003855635
- 3007922509
- 3010097171
- 1834331
- 3012120772
- 3010047454
- 3014252644
- 1223434
- 9617544
- 2029275
- 3010462278
- 3005751028
- 3012447612
- 3005061536
- 2648623
- 1835831
- 3004635447
- 3010123256
- 3009149199
- 3004774118
- 1030489
- 3009241418
- 3004638600
- 1528646
- 3010120326
- 1833920
- 1643817
- 3007344102
- 3010705004
- 3002862271
- 3009144915
- 1450662
- 3009760038
- 3006128100
- 2531195
- 1526439
- 3010370500
- 1833986
- 3008455034
- 2032098
- 3004153896
- 3003935342
- 3009998573
- 2031966
- 9615128
- 3009941480
- 3013491327
- 3041915189
- 2133928
- 3016438694
- 1722511
- 3003387384
- 3014019090
- 3009887475
- 1935627
- 1424434
- 3006783837
- 3010197239
- 3010560653
- 1000517406
- 8020776
- 3005819474
- 1828464
- 3015941638
- 3012994232
- 3006493760
- 3000270450
- 3015207155
- 3043543260
- 9610612
- 3004638532
- 1424263
- 2183946
- 3004024955
- 3010047402
- 3015869492
- 3008534770
- 2032093
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases