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Pyrenees Cervical Plate System Modification

by K2M, Inc.

510(k) K063544

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 NumberK063544 Date14 Feb 2007ClearedStatusActive

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  • Withdrawn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 Pyrenees Cervical Plate System
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 Pyrenees Cervical Plate System Modification is a spinal fixation orthosis classified as an orthopedic device. It consists of titanium plates and screws designed to provide immobilization and stabilization of cervical spine segments (C2–C7) as an adjunct to spinal fusion procedures.

This system is intended for surgical use by physicians to address degenerative conditions, trauma, or spondylolisthesis in the cervical spine. Components are available in multiple sizes to accommodate varying patient anatomy, and the device was cleared under an FDA 510(k) submission (K063544) as a modification to the original Pyrenees system.

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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 cervical spine conditions is the Pyrenees Cervical Plate System Modification designed to address in surgical settings?

    The Pyrenees Cervical Plate System Modification is intended for surgical use to stabilize cervical spine segments (C2–C7) as an adjunct to spinal fusion procedures. It is specifically designed to address degenerative conditions, trauma, or spondylolisthesis in the cervical spine, providing immobilization and support during recovery.

  • How is the Pyrenees Cervical Plate System Modification supplied, and what materials are used in its construction?

    The system is supplied as a surgical orthopedic device consisting of titanium plates and screws. These components are engineered to accommodate varying patient anatomies, with multiple sizes available to ensure proper fit and function during cervical spine stabilization procedures.

  • Is the Pyrenees Cervical Plate System Modification intended for single-use or reusable applications?

    The device is designed for surgical use, which typically implies single-use per patient to maintain sterility and safety. While the data does not explicitly state reuse, spinal fixation hardware like this is generally not intended for repeated use due to sterilization risks and potential compromise of structural integrity.

  • What regulatory pathway was followed for the FDA clearance of this modification to the Pyrenees Cervical Plate System?

    The modification was cleared under an FDA 510(k) submission (K063544) as substantially equivalent to the original Pyrenees system. The submission was reviewed by the Orthopedic (OR) Advisory Committee under a special clearance type, with a decision date of February 14, 2007.