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Bonesave Bone Void Filler

by Howmedica Osteonics

510(k) K033258

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 NumberK033258 Date9 Mar 2004ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

Bonesave Bone Void Filler is a bone void filler device used to fill osseous defects or gaps in bone tissue. It is designed to provide structural support and promote bone regeneration in orthopedic applications.

The device is supplied as a calcium compound material and is intended for single use. It is regulated under FDA 510(k) clearance with product code MQV and is not indicated for MRI compatibility. The device should be stored according to the manufacturer's instructions and is authorized for use in orthopedic procedures.

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Questions

AI-generated answers, 21 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 BONESAVE Bone Void Filler used for?

    The BONESAVE Bone Void Filler is designed to fill osseous defects or gaps in bone tissue, providing structural support and promoting bone regeneration in orthopedic applications.

  • How is the BONESAVE Bone Void Filler supplied and is it single-use?

    The device is supplied as a calcium compound material and is intended for single use only. It should not be reused or resterilized for patient safety and regulatory compliance.

  • What are the storage requirements for the BONESAVE Bone Void Filler?

    The BONESAVE Bone Void Filler should be stored according to the manufacturer's instructions to maintain its integrity and effectiveness until use.

  • Is the BONESAVE Bone Void Filler MRI compatible?

    No, the BONESAVE Bone Void Filler is not indicated for MRI compatibility. It should not be used in patients undergoing MRI procedures.