Gemini-C Hybrid Cervical Interbody System
FDA 510(k) K170844 · Osseus Fusion Systems, LLC
510(k) numberK170844
Submission
- Device name
- Gemini-C Hybrid Cervical Interbody System
- Applicant
- Osseus Fusion Systems, LLC
Dallas, TX, US - Received
- March 21, 2017
- Decision date
- July 3, 2017
- 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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| K223413 | Pisces-SA STANDALONE ALIF Interbody SystemOVD · Traditional | 02/10/2023SE |
| K222107 | Black Diamond POCT Spinal SystemNKG · Traditional | 11/03/2022SE |
| K213935 | PISCES-SA Standalone ALIF Interbody SystemOVD · Traditional | 05/06/2022SE |
| K213590 | Blue Topaz Sacroiliac Screw SystemOUR · Traditional | 03/01/2022SE |
| K192495 | Black Diamond Navigation InstrumentsOLO · Traditional | 01/17/2020SE |
| K192121 | Black Diamond Pedicle Screw SystemNKB · Traditional | 10/29/2019SE |
| K181347 | Aries® Lumbar InterbodiesMAX · Traditional | 08/15/2018SE |
| K160522 | White Pearl Preferred Angle Anterior Cervical PlateKWQ · Traditional | 04/26/2016SE |
| K131810 | Osseus Black Diamond Pedicle Screw SystemMNH · Traditional | 08/08/2013SE |
Questions and answers
When was Gemini-C Hybrid Cervical Interbody System cleared by the FDA?
Gemini-C Hybrid Cervical Interbody System (K170844) received a 510(k) decision of Substantially Equivalent on July 3, 2017, 104 days after the submission was received.
What is the product code of K170844?
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.