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IMSE Cervical Cage

by The Institute of Musculoskeletal Science & Education

510(k) K162003

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162003 Date21 Dec 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IMSE Cervical Cage is an intervertebral fusion device designed for cervical spine applications. Classified under the nomenclature for intervertebral fusion devices with bone graft, it is intended for use in skeletally mature patients to facilitate spinal stabilization at one level from C3 to C7.

This device is supplied as a single-use orthopedic implant and has received FDA 510(k) clearance under the Traditional pathway. It is intended for use following six weeks of non-operative treatment for degenerative disc disease with up to Grade 1 spondylolisthesis. The device is regulated under classification code ODP and falls under the Orthopedic specialty.

Other devices from The Institute of Musculoskeletal Science & Education

  • Imse P-Tlif

    Class II

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the IMSE Cervical Cage used for?

    The IMSE Cervical Cage is an intervertebral fusion device designed for cervical spine applications, intended to facilitate spinal stabilization at one level from C3 to C7 in skeletally mature patients with degenerative disc disease and up to Grade 1 spondylolisthesis after six weeks of non-operative treatment.

  • Is the IMSE Cervical Cage a single-use device?

    Yes, the IMSE Cervical Cage is supplied as a single-use orthopedic implant and should not be reused on multiple patients.

  • What regulatory clearance has the IMSE Cervical Cage received?

    The IMSE Cervical Cage has received FDA 510(k) clearance under the Traditional pathway, classified under product code ODP for orthopedic devices.

  • What levels of the cervical spine can the IMSE Cervical Cage be used at?

    The IMSE Cervical Cage is designed for use at one level of the cervical spine, specifically from the third cervical vertebra (C3) to the seventh cervical vertebra (C7).