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510(k) K162682

MATISSE Anterior Cervical Interbody Fusion Cage System by Ctl Medical Corporation — Product Code ODP

K162682 is an FDA 510(k) premarket notification submitted by Ctl Medical Corporation for the device "MATISSE Anterior Cervical Interbody Fusion Cage System". The FDA issued a decision of Substantially Equivalent on June 1, 2017. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Ctl Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2017
Date Received
September 26, 2016
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 Ctl Medical Corporation

  • K233947 — KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System (October 10, 2024)
  • K231715 — MONDRIAN™ Anterior Lumbar Plate System (January 26, 2024)
  • K231359 — RODIN™ Expandable Lumbar Cage System (June 9, 2023)
  • K220513 — NITRO Interbody Fusion Cage System Family (April 25, 2023)
  • K220334 — MONET Anterior Cervical Plate System (November 9, 2022)
  • K211785 — CASSATT™ SIJ Fixation System (October 17, 2022)
  • K213641 — MONDRIAN ALIF Cage with Supplementary Fixation Plate (September 15, 2022)
  • K213491 — Universal Pilot Guidance Instrument System (May 12, 2022)
  • K192863 — MONDRIAN Lumbar Interbody Fusion Cage System (August 26, 2020)
  • K182151 — MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation (October 11, 2018)

Other clearances for product code ODP

  • K253041 — 3d Cage Cervical (July 23, 2026)
  • 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)

FDA data resources