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Universal Clamp Spinal Fixation System

by Zimmer Spine

510(k) K110348

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 NumberK110348 Date11 Aug 2011ClearedStatusActive

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  • Withdrawn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
OWI
Device class
Class II
Regulation
21 CFR Part 888.3010
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Universal Clamp Spinal Fixation System is a bone fixation device used for spinal applications. It is classified as a sublaminar cerclage device designed to provide stabilization in orthopedic procedures.

The system is supplied as a sterile, single-use device and is not intended for MRI use. It is authorized under FDA 510(k) clearance with product code OWI and has been determined to be substantially equivalent to predicate devices.

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Questions

AI-generated answers, 21 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 Universal Clamp Spinal Fixation System used for?

    The Universal Clamp Spinal Fixation System is a bone fixation device designed for spinal applications. It functions as a sublaminar cerclage device to provide stabilization during orthopedic procedures.

  • How is the Universal Clamp Spinal Fixation System supplied?

    The system is supplied as a sterile, single-use device. It is not intended for MRI use and should be used according to the manufacturer's instructions for each procedure.

  • What is the regulatory status of the Universal Clamp Spinal Fixation System?

    The device is authorized under FDA 510(k) clearance with product code OWI. It has been determined to be substantially equivalent to predicate devices for spinal fixation applications.

  • Can the Universal Clamp Spinal Fixation System be reused?

    No, the Universal Clamp Spinal Fixation System is supplied as a single-use device and should not be reused on multiple patients or procedures to ensure patient safety and device integrity.