510(k) K232348
- Device
- RIGEL? 3DR Standalone Anterior Cervical Interbody Fusion System
- Applicant
- MiRus, LLC
- 510(k) number
- K232348
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-27
- Date received
- 2023-08-07
- 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
- Jordan Bauman
- Address
- 1755 W. Oak Pkwy. Suite 100 Marietta GA US 30062 30062
FDA Registration Numbers#
- 1000517406
- 3037407500
- 3003526896
- 3009241418
- 9615800
- 3018210489
- 3008864603
- 1724955
- 3008850074
- 3010041430
- 3002807112
- 3010560653
- 3015212339
- 3005739886
- 3009957608
- 3005076207
- 3015216945
- 1057425
- 3015398319
- 3010047454
- 3003597504
- 3005031160
- 3013961579
- 3010120104
- 1030489
- 2531195
- 3036042032
- 3012028003
- 3036756245
- 3004142400
- 2648623
- 2134470
- 3014680795
- 1226544
- 3013422236
- 8020776
- 3013820501
- 3010363503
- 3010160527
- 1835251
- 3004774118
- 1834331
- 1834379
- 3043543260
- 9611813
- 3009051471
- 1220477
- 2028632
- 1225492
- 3000270450
- 3004024955
- 3009144915
- 3011795235
- 2183946
- 3017521423
- 3010329663
- 3008455034
- 1319660
- 3048284429
- 9617297
- 3007125392
- 3005677016
- 3007728266
- 3009189869
- 3010863450
- 3023189283
- 2032098
- 3006017180
- 1000461041
- 3005706667
- 3010057495
- 3009887475
- 3004188066
- 2134285
- 3009888740
- 3014273501
- 3009882462
- 3009554293
- 3012131184
- 3015876273
Source Documents#
Other 510(k) Records For Product Code OVE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026-08-21 |
| K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026-07-31 |
| 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 |
| K250540 | SABER-C System | Elevation Spine | 2025-08-08 |
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025-07-30 |