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The Titanium Fixation System

by Biomedics 510(k)

Active United States

510(k) K943071

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943071 Date6 Jan 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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, 27 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 Titanium Fixation System is a bone plate device classified under the dental specialty. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device received FDA 510(k) clearance under K943071 on January 6, 1995, and is manufactured by Biomedics. It is regulated under regulation number 872.4760 and assigned product code JEY.

Other devices from Biomedics

See all devices from Biomedics →

Questions

AI-generated answers, 27 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 Titanium Fixation System used for?

    The Titanium Fixation System is a bone plate device intended for use in dental specialty applications to stabilize bone fragments during healing, based on its classification and clearance as a substantially equivalent device under FDA 510(k) K943071.

  • How is the Titanium Fixation System supplied and is it sterile?

    The device data does not specify sterility, single-use status, or packaging details; therefore, no information about how it is supplied or whether it is sterile can be derived from the provided authorization and specification fields.

  • What sizes or models are available for the Titanium Fixation System?

    The device data does not include any details about sizes, models, dimensions, or reference numbers for the Titanium Fixation System beyond its name and K943071 clearance number, so specific sizing or model variations cannot be determined from this information.

  • What regulatory pathway was used for the Titanium Fixation System?

    The Titanium Fixation System received FDA 510(k) clearance through the traditional pathway under K943071 on January 6, 1995, and was found substantially equivalent to a predicate device, as indicated by the decision code SESE and clearance_type 'Traditional'.