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MasterGraft Putty

by Medtronic Sofamor Danek, Inc. 2 variants

510(k) K071813

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 NumberK071813 Date9 Nov 2007ClearedStatusActive

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  • Withdrawn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
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 888.3045
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.

MasterGraft Putty is a bone graft made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. The collagen component is Type I bovine collagen, and the biphasic ceramic portion is provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation.

MasterGraft Putty is supplied by Medtronic Sofamor Danek, Inc. and has received FDA 510K authorization. It is used in spine and trauma surgery to extend autograft, and is available with specific product codes and sizes, including the referenced K071813 and K140375 clearances.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

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 MasterGraft Putty used for?

    MasterGraft Putty is a bone graft material used in spine and trauma surgery to extend autograft. It combines Type I bovine collagen with a biphasic calcium phosphate ceramic to provide a scaffold for bone healing.

  • What materials are in MasterGraft Putty?

    It contains medical-grade purified Type I bovine collagen and a biphasic calcium phosphate ceramic composed of 15% hydroxyapatite and 85% beta-tricalcium phosphate. This blend supports osteoconduction and resorption.

  • How is MasterGraft Putty supplied?

    It is supplied by Medtronic Sofamor Danek, Inc. and is available in specific sizes and configurations. Product codes K071813 and K140375 correspond to different clearances and configurations.

  • Is MasterGraft Putty sterile and single-use?

    The device data does not specify sterility or single-use status. For clinical use details such as sterilization method and reusability, refer to the product labeling or contact the manufacturer directly.

  • What regulatory authorization does MasterGraft Putty have?

    MasterGraft Putty has received FDA 510K authorization under K-number K071813, with a decision date of November 9, 2007. It was reviewed under product code MQV and classified as substantially equivalent.