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Cervical Plating System

by Life Spine, Inc.

510(k) K243369

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 NumberK243369 Date11 Dec 2024ClearedStatusActive

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  • Withdrawn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
KWQ
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Cervical Plating System is an orthopedic device designed for anterior interbody screw fixation of the cervical spine. It provides internal stabilization to support spinal alignment and promote healing in cervical vertebrae. Constructed for surgical use, the system includes plating components and screws to secure vertebral segments, ensuring structural integrity during recovery. Its design is tailored for precision placement and long-term stability in spinal reconstruction procedures.

This system is supplied sterile and intended for single-use in controlled surgical environments. It is classified under the FDA’s product code KWQ and has received a Traditional 510(k) clearance through the Orthopedic (OR) advisory committee. The device is not MRI-safe and must be handled according to sterile surgical protocols. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality. Authorized use is limited to temporary stabilization of the cervical spine as specified in the FDA submission.

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Questions

AI-generated answers, 20 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 primary purpose of the Cervical Plating System in spinal surgery?

    The Cervical Plating System is designed for anterior interbody screw fixation of the cervical spine, providing internal stabilization to maintain spinal alignment and support healing in cervical vertebrae during reconstruction procedures. It ensures structural integrity during recovery by securing vertebral segments with plating components and screws.

  • Is this device intended for reuse in surgical settings, or is it meant to be used only once?

    The Cervical Plating System is sterile and intended for single-use only in controlled surgical environments. This design ensures patient safety and compliance with sterile protocols, preventing cross-contamination or degradation from repeated use.

  • How should the Cervical Plating System be stored to maintain its integrity and sterility?

    Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and single-use, it should be kept in its original packaging until ready for use, protected from moisture, contamination, and physical damage to ensure proper performance during surgery.

  • Can this device be used with MRI imaging after implantation, or are there restrictions?

    The Cervical Plating System is not MRI-safe, meaning it should not be used in MRI environments due to potential risks of interference, heating, or image artifacts. Pre- and post-operative imaging should use alternative modalities like X-ray or CT scans as clinically indicated.

  • What regulatory pathway did the Cervical Plating System follow to gain market authorization in the U.S.?

    The device received a Traditional 510(k) clearance through the FDA’s Orthopedic (OR) advisory committee, demonstrating it is substantially equivalent to a legally marketed predicate device. The submission was filed under product code KWQ and reviewed by the Orthopedic panel before clearance on December 11, 2024.