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510(k) K192863

MONDRIAN Lumbar Interbody Fusion Cage System by Ctl Medical Corporation — Product Code MAX

K192863 is an FDA 510(k) premarket notification submitted by Ctl Medical Corporation for the device "MONDRIAN Lumbar Interbody Fusion Cage System". The FDA issued a decision of Substantially Equivalent on August 26, 2020. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), 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
August 26, 2020
Date Received
October 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize 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)
  • K182151 — MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation (October 11, 2018)
  • K172788 — MONET™ Anterior Cervical Interbody Fusion Cage System (June 25, 2018)

Other clearances for product code MAX

  • K261430 — TruLift Expandable System (July 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)

FDA data resources