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Max-Face Maxillofacial Osteosynthesis System

by Bio-Technology USA, Inc.

510(k) K073307

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073307 Date29 Oct 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
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 Max-Face Maxillofacial Osteosynthesis System is a bone plate and screw system designed for internal fixation in craniomaxillofacial surgery. It is indicated for the trauma fixation of the superior, middle, and inferior segments of the facial skeleton, as well as for the osteosynthesis of corrective procedures.

This system is available in four kit sizes: Cranio, Micro, Standard, and Macro. It is regulated under FDA 510(k) clearance K073307 as a Class 2 device.

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 Max-Face Maxillofacial Osteosynthesis System used for?

    This system is designed for internal fixation during craniomaxillofacial surgery. It is specifically indicated for trauma fixation of the superior, middle, and inferior segments of the facial skeleton, as well as for the osteosynthesis of corrective procedures.

  • What kit sizes are available for this system?

    The system is available in four distinct kit sizes to accommodate different surgical requirements: Cranio, Micro, Standard, and Macro.

  • What is the regulatory status of this device?

    The Max-Face Maxillofacial Osteosynthesis System is a Class 2 device that has received FDA 510(k) clearance under the number K073307.