FDA 510(k)

MONET™ Anterior Cervical Interbody Fusion Cage System

K-Number: K172788 · 2018-06-25

Decision Date2018-06-25

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MONET™ Anterior Cervical Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2018-06-25 under 510(k) number K172788. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONET™ Anterior Cervical Interbody Fusion Cage System?

MONET™ Anterior Cervical Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Ctl Medical Corporation. The 510(k) number is K172788.

When did MONET™ Anterior Cervical Interbody Fusion Cage System receive FDA 510(k) clearance?

MONET™ Anterior Cervical Interbody Fusion Cage System received FDA 510(k) clearance on 2018-06-25, under 510(k) number K172788.

Who is the listed applicant for MONET™ Anterior Cervical Interbody Fusion Cage System?

The FDA 510(k) record lists Ctl Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONET™ Anterior Cervical Interbody Fusion Cage System?

The FDA product code for MONET™ Anterior Cervical Interbody Fusion Cage System is ODP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION NCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING NCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED NCT04388332ACDF Using Structural Allograft vs. Tritanium CRECRUITING NCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITING

Other records listing Ctl Medical Corporation as applicant

K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System K231715MONDRIAN™ Anterior Lumbar Plate System K231359RODIN™ Expandable Lumbar Cage System K220513NITRO Interbody Fusion Cage System Family K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System

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Related Devices (Code: ODP)

K2530413d Cage CervicalFims Co., Ltd.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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.