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Uni-FuZe-P Bone Putty

by Zavation Medical Products, LLC

510(k) K201781

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 NumberK201781 Date28 Dec 2020ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Uni-FuZe-P Bone Putty is a resorbable calcium salt bone void filler. It is classified as a Class II device under product code MQV and regulation number 21 CFR 888.3045.

The device is supplied sterile and ready for use without hydration. It is intended for use in orthopedic procedures as a bone void filler and has received FDA 510(k) clearance under K201781.

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Questions

AI-generated answers, 24 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 Uni-FuZe-P Bone Putty used for?

    Uni-FuZe-P Bone Putty is intended for use as a bone void filler in orthopedic procedures, providing a resorbable calcium salt material to fill bony defects or gaps where bone growth is desired.

  • Is Uni-FuZe-P Bone Putty supplied sterile and ready to use?

    Yes, Uni-FuZe-P Bone Putty is supplied sterile and ready for use without the need for hydration or additional preparation, allowing immediate application during surgery.

  • What regulatory clearance does Uni-FuZe-P Bone Putty have?

    Uni-FuZe-P Bone Putty has received FDA 510(k) clearance under submission number K201781, demonstrating substantial equivalence to a legally marketed predicate device for its intended use.