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Claris Plate System

by Ortho Tec, LLC

510(k) K010369

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 NumberK010369 Date8 May 2001ClearedStatusActive

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  • Withdrawn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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
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 Claris Plate System is an orthopedic spinal implant assembly classified as a spinal fixation device under the FDA’s nomenclature. It consists of plates, screws, longitudinal members, and interconnection mechanisms designed to stabilize and support the spine during surgical procedures, providing structural reinforcement to the vertebral column.

This system is intended for surgical use in spinal fixation procedures and is supplied as a sterile, single-use device. It is regulated under FDA 510(k) clearance (K010369) and falls under the Orthopedic (OR) advisory committee classification. The device is supplied in a sterile package and must be handled according to standard surgical protocols to ensure proper implantation and patient safety.

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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 spinal procedures is the Claris Plate System designed for, and how does it provide stabilization?

    The Claris Plate System is specifically designed for surgical spinal fixation procedures to stabilize and reinforce the vertebral column. It achieves this through its assembly of plates, screws, longitudinal members, and interconnection mechanisms, which work together to provide structural support during and after surgery. This system is intended for use in orthopedic spinal surgeries where rigid fixation is required.

  • Is the Claris Plate System reusable or intended for single-use only, and how should it be handled?

    The Claris Plate System is supplied as a sterile, single-use device. It must be handled according to standard surgical protocols to maintain sterility and ensure proper implantation. Reuse is not recommended or supported, as this could compromise patient safety and device integrity.

  • How is the Claris Plate System packaged and stored, and what precautions should be taken?

    The Claris Plate System comes in a sterile package, designed to preserve its integrity until use. Storage should follow standard surgical guidelines to prevent contamination. The package should remain unopened until immediately before surgery, and the device should be handled with sterile techniques to avoid compromising its sterility.

  • What regulatory pathway was followed for the FDA clearance of the Claris Plate System, and who is the applicant?

    The Claris Plate System received FDA clearance through a 510(k) submission, specifically under the traditional review pathway, and was determined to be substantially equivalent to a predicate device. The applicant for this clearance was Ortho Tec, LLC, based in Beverly Hills, CA. The system falls under the Orthopedic (OR) advisory committee classification.