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Xomed Mandibular Tray

by Xomed, Inc. 510(k)

Active United States

510(k) K821904

Overview

The Xomed Mandibular Tray is a Prosthesis, Facial, Mandibular Implant (product code JAZ) designed to support surgical procedures in the mandibular region. It serves as a protective or stabilizing tray during otolaryngologic interventions, particularly in ear, nose, and throat (ENT) surgeries, ensuring anatomical alignment and access.

This device is supplied sterile and intended for single-use, adhering to FDA Class II regulatory standards under Regulation 874.3695. It is cleared for use in controlled surgical environments, with no noted MRI compatibility restrictions. The tray is available in the specified model referenced by product code JAZ and was authorized via a Traditional 510(k) clearance (K821904) in 1982, classified under the Ear, Nose, and Throat advisory committee.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821904 Date26 Jul 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
JAZ
Device Class
Class II
Regulation
21 CFR Part 874.3695
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Xomed Mandibular Tray (JAZ) used for?

    The Xomed Mandibular Tray (JAZ) is a facial prosthesis designed specifically for mandibular region surgeries in otolaryngology (ENT). It acts as a protective or stabilizing tray to maintain anatomical alignment and provide clear access during procedures involving the ear, nose, and throat. This ensures precision and safety during interventions where mandibular stability is critical.

  • Is the Xomed Mandibular Tray (JAZ) sterile and single-use?

    Yes, the Xomed Mandibular Tray (JAZ) is supplied sterile and intended for single-use only. This design minimizes cross-contamination risks and ensures optimal surgical conditions by maintaining sterility throughout the procedure.

  • What regulatory approval does the Xomed Mandibular Tray (JAZ) hold?

    The Xomed Mandibular Tray (JAZ) holds FDA clearance under a Traditional 510(k) pathway (K821904), classified as substantially equivalent to a predicate device. It adheres to FDA Class II regulatory standards under Regulation 874.3695 and is intended for use in controlled surgical environments.

  • Are there any compatibility restrictions for the Xomed Mandibular Tray (JAZ)?

    The Xomed Mandibular Tray (JAZ) has no noted MRI compatibility restrictions, meaning it can be safely used in surgical settings where MRI imaging may be required. Always verify compatibility with specific imaging protocols and equipment in your facility.

  • How is the Xomed Mandibular Tray (JAZ) supplied, and what sizes are available?

    The Xomed Mandibular Tray (JAZ) is supplied sterile and packaged for single-use. While the specifications do not list multiple sizes, it is designed to fit standard mandibular anatomical requirements for ENT surgeries. For exact fitment, consult the manufacturer’s surgical planning guidelines or contact Xomed, Inc. for further details.