510(k) K240416
- Device
- Tranquil-C Interbody System
- Applicant
- Nexus Spine, LLC
- 510(k) number
- K240416
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-12
- Date received
- 2024-02-12
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Jared Crocker
- Address
- 2825 E. Cottonwood Pkwy. Suite 330 Salt Lake City UT US 84121 84121
FDA Registration Numbers
- 3013961579
- 3009962553
- 3006563559
- 3009957608
- 3008110533
- 3010047454
- 3009049161
- 1047843
- 2032521
- 3008868758
- 2028632
- 2245304
- 1928237
- 3014725904
- 3006378738
- 3010097171
- 3011301313
- 3022295665
- 2031966
- 8010273
- 3009756327
- 3007887127
- 3010560653
- 3004024955
- 3000170817
- 1220477
- 3024999441
- 3009888740
- 3003761012
- 3008583793
- 3018210489
- 3010160527
- 3017528621
- 3005031160
- 3009417901
- 3015831087
- 3012120772
- 3027807601
- 3017065977
- 3013422236
- 3005751028
- 1935627
- 1649379
- 2134285
- 1828464
- 1834331
- 1054811
- 3009941480
- 3009217531
- 3006082533
- 1030489
- 1424263
- 3015941638
- 3009051471
- 3017936978
- 3025602479
- 3007766698
- 9611390
- 3030412764
- 2032098
- 1529009
- 1833920
- 3012764194
- 3004464325
- 3012131184
- 3009106092
- 3010057495
- 3009129735
- 3004941535
- 3007675554
- 3007441485
- 3021006165
- 3016237080
- 3010120135
- 3015151147
- 3010039400
- 3002807112
- 1319660
- 3031081659
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B678522460S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224600 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522459S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224590 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522458S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224580 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522457S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224570 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522456S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224560 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522455S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224550 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522454S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224540 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B678522453S0 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
| B6785224530 | Tranquil-C Interbody System | NEXUS SPINE, L.L.C. | 2025-08-31 |
Other 510(k) Records For Product Code ODP
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | 2026-05-12 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026-04-24 |
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | 2026-04-13 |
| K242303 | MOD-C | Orthomod, LLC | 2026-04-01 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026-03-30 |
| K252432 | Flex-Z Cervical Cage | Spinepoint, LLC | 2026-03-25 |
| K254105 | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | 2026-02-13 |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2026-01-16 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | 2026-01-15 |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026-01-14 |
| K252711 | Advantage-C Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | 2026-01-08 |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026-01-06 |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | 2025-12-19 |