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Osteomed Tram

by Osteomed Corp.

510(k) K963394

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963394 Date14 Nov 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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, 1 Oct 2026

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

The Osteomed Tram is a Plate, Bone (per FDA classification 872.4760), designed to stabilize fractured bone structures in the oral cavity. It functions by securing bone segments to the plate via screws, preventing movement and aiding proper healing during mandibular or maxillofacial reconstruction.

This device is intended for single-use in dental settings and is classified as a Class II medical device under FDA regulations. Supplied sterile, it requires no additional sterilization before use. The Tram is available in multiple sizes (referenced by FEI numbers in the product code JEY) and is regulated under the Dental advisory committee. Its clearance (K963394) was granted as Substantially Equivalent in 1996.

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