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Stimulan Calcium Sulfate Bone Void Filler

by Encore Orthopedics, Inc.

510(k) K982663

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 NumberK982663 Date26 Feb 1999ClearedStatusActive

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  • Withdrawn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.

The Stimulan Calcium Sulfate Bone Void Filler is a bone void filler provided as sterile, biodegradable, radiopaque calcium sulfate pellets. It is used in clinical settings to fill bone voids where autologous graft is unavailable or infection risk exists. The implant resorbs over 30-60 days and is replaced by natural bone during healing.

The device is supplied as a sterile product and is intended for single-use. It is available in the form of pellets and is used by physicians in clinical settings. The device has been assigned the product code MQV and has been found to be substantially equivalent by the FDA. It is stored at a location with the address 9800 Metric Blvd, Austin, TX 78758.

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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 Stimulan Calcium Sulfate Bone Void Filler used for?

    The Stimulan Calcium Sulfate Bone Void Filler is used to fill bone voids where autologous graft is unavailable or infection risk exists, allowing natural bone to replace the implant during healing.

  • Is the Stimulan Calcium Sulfate Bone Void Filler sterile?

    Yes, the Stimulan Calcium Sulfate Bone Void Filler is supplied as a sterile product, reducing the risk of infection.

  • How long does the Stimulan Calcium Sulfate Bone Void Filler take to resorb?

    The implant resorbs over 30-60 days, allowing natural bone to replace it during the healing process.

  • Is the Stimulan Calcium Sulfate Bone Void Filler intended for single-use?

    Yes, the Stimulan Calcium Sulfate Bone Void Filler is intended for single-use, ensuring patient safety and reducing the risk of infection.