MATRIX HA PEEK Cervical IBF System
FDA 510(k) K232619 · Sapphire Medical Group
510(k) numberK232619
Submission
- Device name
- MATRIX HA PEEK Cervical IBF System
- Applicant
- Sapphire Medical Group
Dana Point, CA, US - Received
- August 29, 2023
- Decision date
- March 19, 2024
- 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 |
|---|---|---|
| K192316 | Matrix HA PEEK Cervical Implant SystemODP · Special | 10/17/2019SE |
| K183073 | SMG Anterior Cervical Plate SystemKWQ · Traditional | 02/11/2019SE |
| K172674 | Sapphire Cervical Implant SystemODP · Special | 11/02/2017SE |
| K121693 | A-Wedge Anterior Interbody System (A-Wedge Ais)MAX · Traditional | 12/27/2012SE |
Questions and answers
When was MATRIX HA PEEK Cervical IBF System cleared by the FDA?
MATRIX HA PEEK Cervical IBF System (K232619) received a 510(k) decision of Substantially Equivalent on March 19, 2024, 203 days after the submission was received.
What is the product code of K232619?
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.