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Sentry Posterior Spinal System

by Sofamor Danek Mfg., Inc.

510(k) K930710

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930710 Date1 Oct 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Sentry Posterior Spinal System is a spinal fixation device designed for use in posterior spinal procedures. It is classified as an Appliance, Fixation, Spinal Interlaminal device and is intended to provide stabilization and support to the spinal column.

The system is supplied by Sofamor Danek Mfg., Inc. and has received FDA 510(k) clearance with the number K930710. It is a Class II device with Special Controls and is intended for single-use or multiple-use as specified by the manufacturer. The device is not indicated for MRI use and should be stored according to the manufacturer's instructions.

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Questions

AI-generated answers, 25 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 Sentry Posterior Spinal System used for?

    The Sentry Posterior Spinal System is a spinal fixation device designed for use in posterior spinal procedures to provide stabilization and support to the spinal column.

  • Is the Sentry Posterior Spinal System single-use or reusable?

    The system is intended for single-use or multiple-use as specified by the manufacturer, Sofamor Danek Mfg., Inc.

  • What regulatory clearance has the Sentry Posterior Spinal System received?

    The device has received FDA 510(k) clearance with number K930710 and is classified as a Class II device with Special Controls.

  • How should the Sentry Posterior Spinal System be stored?

    The device should be stored according to the manufacturer's instructions, which are provided by Sofamor Danek Mfg., Inc.

  • Can the Sentry Posterior Spinal System be used with MRI?

    No, the device is not indicated for MRI use and should not be used in MRI procedures.