Velofix Interbody Fusion System
FDA 510(k) K190067 · U&I Corporation
510(k) numberK190067
Submission
- Device name
- Velofix Interbody Fusion System
- Applicant
- U&I Corporation
Uijeongbu-Si, KR - Received
- January 15, 2019
- Decision date
- February 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K220147 | Aspiron S ACP SystemKWQ · Special | 02/16/2022SE |
| K210573 | Velofix SA Cervical CageOVE · Traditional | 11/19/2021SE |
| K183243 | Velofix TLIF CageMAX · Special | 07/10/2019SE |
| K190053 | SECULOK ACP SystemKWQ · Special | 02/01/2019SE |
| K181824 | CBT Screw Fixation SystemNKB · Traditional | 12/13/2018SE |
| K183383 | ANAX OCT Spinal SystemNKG · Special | 12/12/2018SE |
| K181829 | Velofix TLIF CageMAX · Special | 11/14/2018SE |
| K182055 | SECULOK ACP SystemKWQ · Traditional | 09/10/2018SE |
| K180759 | SECULOK Suture AnchorMBI · Traditional | 08/09/2018SE |
| K173198 | Facet Screw Fixation SystemMRW · Traditional | 01/03/2018SE |
Questions and answers
When was Velofix Interbody Fusion System cleared by the FDA?
Velofix Interbody Fusion System (K190067) received a 510(k) decision of Substantially Equivalent on February 4, 2019, 20 days after the submission was received.
What is the product code of K190067?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.