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Remedy Cervical Plate

by Archimed, Inc.

510(k) K100215

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 NumberK100215 Date7 Apr 2010ClearedStatusActive

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  • Withdrawn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
Archimed Remedy Cervical Plate
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, 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 Remedy Cervical Plate is a spinal fixation device classified as an orthopedic cervical spine plate system. It consists of titanium alloy (ASTM F136) bone plates and screws designed to provide temporary fixation to the cervical spine (C2–T1) during anterior fusion procedures.

Used via an anterior surgical approach, the system includes various plate shapes and screw sizes for secure vertebral fixation. Implant components are non-sterile and intended for single-use, with regulatory clearance granted under FDA 510(k) K100215 as substantially equivalent to a predicate device. Storage and handling follow standard orthopedic implant protocols.

Questions

AI-generated answers, 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.

  • What types of cervical spine procedures is the Remedy Cervical Plate designed to support, and how is it applied during surgery?

    The Remedy Cervical Plate is designed for anterior fusion procedures on the cervical spine, specifically for vertebral levels C2 through T1. It is applied via an anterior surgical approach, where the titanium alloy plate and screws provide temporary fixation to stabilize the spine during the fusion process. The system includes various plate shapes and screw sizes to ensure secure attachment to the vertebrae.

  • Is the Remedy Cervical Plate reusable, or is it intended for single-use only? How should it be stored?

    The Remedy Cervical Plate is intended for single-use only, as explicitly stated in the manufacturer’s instructions. Since the components are non-sterile, they must be sterilized by the surgical facility prior to use following standard orthopedic implant protocols. Proper storage should adhere to guidelines for metallic implants to maintain integrity and sterility until sterilization.

  • What material is the Remedy Cervical Plate made from, and why does this matter for spinal fixation?

    The Remedy Cervical Plate is made from titanium alloy (ASTM F136), a material chosen for its biocompatibility, strength-to-weight ratio, and resistance to corrosion. These properties make titanium ideal for spinal fixation, as it integrates well with bone tissue while providing durable support during the fusion process without triggering adverse reactions.

  • How do I verify the regulatory clearance status of this device before purchasing?

    The Remedy Cervical Plate holds FDA 510(k) clearance (K100215), determined under the Traditional Review pathway as substantially equivalent to a predicate device. To verify its status, you can check the FDA’s Premarket Notification (510(k)) Database using the K-number (K100215) or the product code (KWQ). This clearance confirms it meets FDA requirements for spinal fixation devices in the orthopedic category.