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Confirm Bioactive

by Globus Medical, Inc.

510(k) K133678

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 NumberK133678 Date26 Aug 2014ClearedStatusActive

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  • Withdrawn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
MQV
Device class
Class II
Regulation
21 CFR Part 888.3045
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Confirm Bioactive is a bone void filler and autograft extender intended for use in voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone.

The device is supplied as a bioactive material that can be gently packed into bony voids or gaps of the skeletal system, including the extremities, pelvis, and other areas. It is FDA 510(k) cleared with product code MQV and was reviewed by the Orthopedic advisory committee.

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See all devices from Globus Medical, Inc. →

Questions

AI-generated answers, 26 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 Confirm Bioactive used for?

    Confirm Bioactive is a bone void filler and autograft extender intended for use in voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone.

  • How is Confirm Bioactive supplied?

    The device is supplied as a bioactive material that can be gently packed into bony voids or gaps of the skeletal system, including the extremities, pelvis, and other areas.

  • What is the regulatory status of Confirm Bioactive?

    Confirm Bioactive is FDA 510(k) cleared with product code MQV and was reviewed by the Orthopedic advisory committee. It is classified as substantially equivalent.

  • Can Confirm Bioactive be used in load-bearing areas?

    No, Confirm Bioactive is intended for use in voids or gaps that are not intrinsic to the stability of the bony structure, meaning it should not be used in load-bearing areas.