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510(k) K190618

RIGEL PEEK Anterior Cervical Interbody Fusion System by MiRus, LLC — Product Code ODP

K190618 is an FDA 510(k) premarket notification submitted by MiRus, LLC for the device "RIGEL PEEK Anterior Cervical Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on June 6, 2019. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. MiRus, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2019
Date Received
March 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by MiRus, LLC

  • K253444 — EUROPA™ Posterior Cervical Fusion Navigated Instruments (March 18, 2026)
  • K252733 — ATLAS™ Expandable Osteotomy Wedge System (February 19, 2026)
  • K242516 — EUROPA™ Posterior Cervical Fusion System (November 19, 2024)
  • K241175 — MiRus MoRe Lumbar Plating System (May 17, 2024)
  • K232348 — RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System (October 27, 2023)
  • K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy System (October 13, 2023)
  • K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (September 11, 2023)
  • K230369 — EUROPA™ Navigated Instruments (June 23, 2023)
  • K220441 — CYGNUS™ MoRe Anterior Cervical Plate System (September 16, 2022)
  • K220115 — ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System (May 13, 2022)

Other clearances for product code ODP

  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources