510(k) K182151
- Device
- MONET Anterior Cervical Interbody Fusion Cage System With Supplementary Fixation Plate
- Applicant
- CTL Medical Corporation
- 510(k) number
- K182151
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-11
- Date received
- 2018-08-08
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andrea Wilcox
- Address
- 4550 Excel Pkwy. Suite 300 Addison TX US 75001 75001
FDA Registration Numbers#
- 3010123206
- 1219518
- 1835251
- 3004049923
- 2183946
- 3009189869
- 3009380063
- 3003525643
- 3016084569
- 3013055499
- 3016112537
- 1824199
- 3012131184
- 3016438694
- 3010370500
- 3012447612
- 3021180147
- 9681465
- 3017936978
- 3036042032
- 3006563559
- 3015876273
- 3040266825
- 3005497913
- 3011795235
- 1450662
- 2031917
- 3033739814
- 3010057495
- 3010041499
- 3009962553
- 3003387384
- 1000432246
- 3041915189
- 3005031160
- 3008868758
- 3013422238
- 3015877656
- 1649379
- 3010863450
- 2531195
- 2134285
- 3003639920
- 3015212339
- 3017565094
- 1225492
- 3010120104
- 3008812560
- 1000461041
- 3005977257
- 1833920
- 3011187779
- 1030489
- 3027807601
- 2032093
- 1057425
- 3012028003
- 1724955
- 3011181154
- 1529009
- 3010009693
- 3009882675
- 1935627
- 3012711663
- 9615766
- 8043792
- 3014680795
- 3009959868
- 1834331
- 3007344102
- 3010047402
- 3004719693
- 3005677016
- 3009217531
- 3009756327
- 3010120135
- 3009973505
- 3014655115
- 2134470
- 3017521423
Source Documents#
Other 510(k) Records For Product Code OVE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263113 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-10-02 |
| K262726 | NeckTune™ SA Cervical Cage | Medyssey Co., Ltd. | 2026-09-29 |
| K263049 | SABER-C System | Elevation Spine | 2026-09-23 |
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026-08-21 |
| K262094 | E3D™-C Interbody System | Evolution Spine | 2026-07-22 |
| K261279 | DeltaNEC Interbody System | Nexus Spine | 2026-06-22 |
| K252982 | CONDUIT™ ZERO-P™ VA Secured Spacer System | Avalign Technologies, Inc. | 2026-06-18 |
| K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026-06-15 |
| K260660 | SABER-C System | Elevation Spine | 2026-04-27 |
| K253213 | SAGI Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| K252774 | Uni-C Cervical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| K260038 | E3D™-C Interbody System | Evolution Spine | 2026-02-04 |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025-12-22 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025-09-25 |
Legacy Summary#
summary
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