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Stryker Spine Oasys System

by Stryker Spine 2 variants

510(k) K080143

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 · Special NumberK080143 Date14 Feb 2008ClearedStatusActive

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  • Withdrawn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)

Full name
Modification to Stryker Spine Oasys System
510(k) Number
FDA Product Code
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
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 Stryker Spine Oasys System is a spinal fixation system designed to provide stabilization to promote fusion in the cervical and upper thoracic spine from C1 to T3. The system consists of rods, polyaxial screws, bone screws, hooks, connectors, occiput plates, cross connector plates, connector blockers, and nuts.

These components are available in a variety of lengths to accommodate patient anatomy and are implanted by surgeons during spinal procedures. This device is subject to FDA 510(k) clearance.

Other devices from Stryker Spine

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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 intended use of the Stryker Spine Oasys System?

    The Oasys System is a spinal fixation device designed to provide stabilization to the cervical and upper thoracic spine. It is intended to promote fusion in the region spanning from C1 to T3.

  • What components are included in the Oasys spinal fixation system?

    The system is comprised of a variety of hardware components including rods, polyaxial screws, bone screws, hooks, connectors, occiput plates, cross connector plates, connector blockers, and nuts. These are available in different lengths to accommodate specific patient anatomy.

  • What is the regulatory status of this device?

    The Modification to Stryker Spine Oasys System is subject to FDA 510(k) clearance. It was determined to be substantially equivalent to existing devices under the K080143 submission.