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Apatight HA-Bone Graft Substitute

by Cerabio, LLC

510(k) K013960

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 NumberK013960 Date23 May 2002ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

Apatight HA-Bone Graft Substitute is a porous hydroxyapatite bone graft substitute designed for the repair of bony defects. It features a trabecular structure that mimics human cancellous bone and provides an osteoconductive scaffold for bone regeneration.

The device is supplied in block and granular forms in a sterile condition. It is implanted by surgeons into bony voids or gaps, placed in direct contact with viable host bone. The device has FDA 510(k) clearance with product code MQV and is classified as a Filler, Bone Void, Calcium Compound in the orthopedic medical specialty.

Other devices from Cerabio, LLC

Questions

AI-generated answers, 22 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 APATIGHT HA-Bone Graft Substitute used for?

    The APATIGHT HA-Bone Graft Substitute is designed for the repair of bony defects. It provides an osteoconductive scaffold for bone regeneration when implanted into bony voids or gaps in direct contact with viable host bone.

  • In what forms is the APATIGHT HA-Bone Graft Substitute supplied?

    The device is supplied in both block and granular forms, and it is provided in a sterile condition for surgical implantation. These different forms allow surgeons to select the most appropriate option for specific bony defect repairs.

  • What is the regulatory status of the APATIGHT HA-Bone Graft Substitute?

    The device has FDA 510(k) clearance with product code MQV and is classified as a Filler, Bone Void, Calcium Compound in the orthopedic medical specialty. It received clearance through the traditional pathway with a decision of substantial equivalence.

  • How does the structure of APATIGHT HA-Bone Graft Substitute benefit bone regeneration?

    The device features a trabecular structure that mimics human cancellous bone, providing an osteoconductive scaffold. This structure promotes bone regeneration by allowing bone cells to migrate into and through the material, facilitating new bone formation.