Republic Spine Restore Cervical Interbody Fusion System
FDA 510(k) K190889 · Republic Spine, LLC
510(k) numberK190889
Submission
- Device name
- Republic Spine Restore Cervical Interbody Fusion System
- Applicant
- Republic Spine, LLC
Boca Raton, FL, US - Received
- April 5, 2019
- Decision date
- June 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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| 510(k) | Device | Decision |
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| K223096 | Dark Star Deformity Pedicle Screw SystemNKB · Traditional | 05/26/2023SE |
| K212028 | Dark Star Navigation Instrument SystemOLO · Traditional | 09/27/2021SE |
| K201420 | Republic Spine Dark Star Spinal SystemNKB · Traditional | 03/05/2021SE |
| K190398 | Republic Spine Restore Intervertebral Body Fusion SystemMAX · Traditional | 09/12/2019SE |
| K181495 | Republic Spine Dark Star Spinal SystemNKB · Special | 07/25/2018SE |
| K150283 | Republic Spine Dark Star Spinal SystemMNH · Traditional | 04/29/2015SE |
Questions and answers
When was Republic Spine Restore Cervical Interbody Fusion System cleared by the FDA?
Republic Spine Restore Cervical Interbody Fusion System (K190889) received a 510(k) decision of Substantially Equivalent on June 19, 2019, 75 days after the submission was received.
What is the product code of K190889?
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.