FDA.reportPublic FDA data

510(k) K232619

Device
MATRIX HA PEEK Cervical IBF System
Applicant
Sapphire Medical Group
510(k) number
K232619
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-19
Date received
2023-08-29
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anthony Ruggiero
Address
32565 B Golden Lantern St. Suite 113 Dana Point CA US 92629 92629

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine2026-07-17
K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC2026-07-08
K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.2026-05-16
K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.2026-05-12
K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.2026-04-24
K253260ORIO-3D Cage SystemSpineCraft2026-04-16
K260340HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGESHC Biologics, LLC2026-04-13
K242303MOD-COrthomod, LLC2026-04-01
K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine2026-03-30
K252432Flex-Z™ Cervical CageSpinepoint, LLC2026-03-25
K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC2026-02-13
K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2026-01-16
K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.2026-01-15
K252219Cervical Interbody and VBR Fusion SystemSync Surgical2026-01-14
K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies2026-01-08