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Modus Sagittal Split Plate

by The Straumann Co.

510(k) K993862

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 NumberK993862 Date29 Dec 1999ClearedStatusActive

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  • Withdrawn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, 19 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 Modus Sagittal Split Plate is a bone plate designed for mandibular fixation following sagittal split osteotomy, classified as a bone plate under FDA category JEY. It provides mechanical stabilization to support bone healing in oral and maxillofacial procedures, ensuring rigid fixation of segmented mandibular bone.

This device is supplied as a reusable medical instrument, intended for use in surgical settings by trained professionals. It includes U-shaped plates (0.7 mm thick) with either 6 or 8 screw holes and a 10 mm diameter slider. Authorized under FDA 510(k) clearance (K993862), it adheres to regulatory standards for dental orthopedic fixation devices under classification II.

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