Skip to content

Medical Concepts Interbody Fusion System

by Medical Concepts, Inc.

510(k) K110659

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 NumberK110659 Date13 Sep 2011ClearedStatusActive

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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Medical Concepts Interbody Fusion System is an orthopedic device intended for spinal interbody fusion procedures. It is designed to facilitate bone growth between adjacent vertebrae to stabilize the spine.

The system is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user. It is used in hospital or surgical center settings and has received FDA 510(k) clearance under product code MAX, with K-number K110659.

Other devices from Medical Concepts

Questions

AI-generated answers, 23 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 Medical Concepts Interbody Fusion System used for?

    The system is used for spinal interbody fusion procedures to stabilize the spine by facilitating bone growth between adjacent vertebrae.

  • Is the Medical Concepts Interbody Fusion System supplied sterile?

    No, the system is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user.

  • What type of settings is the Medical Concepts Interbody Fusion System used in?

    The system is used in hospital or surgical center settings.