510(k) K254061
- Device
- Curiteva Porous PEEK Cervical Interbody Fusion System
- Applicant
- Curiteva, Inc.
- 510(k) number
- K254061
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-15
- Date received
- 2025-12-17
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Eric Linder
- Address
- 25127 Will Mccomb Dr. Tanner AL US 35671 35671
FDA Registration Numbers
- 3015709929
- 1450662
- 3021006165
- 3013820501
- 3010763958
- 2027062
- 3009394448
- 3004464325
- 3023852420
- 1834331
- 3009962553
- 1833824
- 3002807112
- 2032521
- 2031093
- 3009504230
- 1219655
- 3036503733
- 3000170817
- 1319660
- 3003678543
- 3021945817
- 3012429289
- 3009756327
- 3010863450
- 3019767615
- 3033739814
- 3006128100
- 3019837678
- 1030489
- 3004719693
- 3031081659
- 1649379
- 2183449
- 1060840
- 3004024955
- 3012120772
- 3005751028
- 3017048829
- 3009189869
- 3009887475
- 9616680
- 3023138345
- 3010047454
- 3009973505
- 3009554293
- 3010287685
- 3012447612
- 3011513267
- 2030598
- 1530390
- 3006017180
- 3016237080
- 1835296
- 3007887127
- 3003898943
- 3008599979
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3004893332
- 1833986
- 1528646
- 3023189283
- 1722511
- 3011181154
- 3036042032
- 3009165919
- 1836116
- 3019356409
- 3022295665
- 3010370500
- 3004788213
- 3009144915
- 8043792
- 3007485169
- 3018094310
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| 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 |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | 2025-12-05 |