Reliance Cervical IBF System
FDA 510(k) K173102 · Reliance Medical Systems, LLC
510(k) numberK173102
Submission
- Device name
- Reliance Cervical IBF System
- Applicant
- Reliance Medical Systems, LLC
Bountiful, UT, US - Received
- September 29, 2017
- Decision date
- December 29, 2017
- 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 |
|---|---|---|
| K202266 | Reliance Cervical IBF SystemODP · Traditional | 03/29/2022SE |
| K210874 | Reliance Spinal Screw SystemNKB · Special | 05/13/2021SE |
| K183049 | Reliance Lumbar IBF SystemMAX · Special | 02/15/2019SE |
| K181118 | Reliance Lumbar IBF SystemOVD · Traditional | 01/09/2019SE |
| K180687 | Reliance Lumber IBF SystemMAX · Special | 05/15/2018SE |
| K173283 | Reliance Lumbar IBF SystemMAX · Special | 01/19/2018SE |
| K172489 | Reliance Cervical IBF SystemODP · Special | 09/07/2017SE |
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | 12/02/2016SE |
| K160463 | Reliance Lumbar IBF SystemMAX · Special | 05/20/2016SE |
| K152131 | Reliance Spinal Screw SystemMNI · Special | 09/17/2015SE |
Questions and answers
When was Reliance Cervical IBF System cleared by the FDA?
Reliance Cervical IBF System (K173102) received a 510(k) decision of Substantially Equivalent on December 29, 2017, 91 days after the submission was received.
What is the product code of K173102?
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.