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Delphos Implants Rigid Fixation System

by Delphos Implants - Ind.Com. Importacao E Exportacao DE 510(k)

Active United States

510(k) K182609

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182609 Date29 Mar 2019ClearedStatusActive

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  • Withdrawn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, 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 Delphos Implants Rigid Fixation System is a bone plate device intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction. It is classified as a Class II medical device under FDA regulation 872.4760 and has received FDA 510(k) clearance (K182609) as substantially equivalent to a predicate device.

The system is supplied as single-use implants and is intended for use in dental and maxillofacial surgical settings. It is manufactured by Delphos Implants - Ind.Com. Importacao E Exportacao DE and is not MRI conditional or reusable based on the provided data. Storage and handling should follow manufacturer instructions, though specific conditions are not detailed in the supplied information.

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 Delphos Implants Rigid Fixation System used for?

    The Delphos Implants Rigid Fixation System is a bone plate device intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction procedures.

  • Is the Delphos Implants Rigid Fixation System reusable or single-use?

    The system is supplied as single-use implants and is not reusable based on the provided information. It is intended for one-time use in dental and maxillofacial surgical settings.

  • What regulatory approvals does the Delphos Implants Rigid Fixation System have?

    The Delphos Implants Rigid Fixation System has received FDA 510(k) clearance (K182609) as substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulation 872.4760.

  • Are there specific storage and handling requirements for the Delphos Implants Rigid Fixation System?

    Storage and handling should follow manufacturer instructions, though specific conditions are not detailed in the supplied information. Users should consult the manufacturer's guidelines for proper storage requirements.