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Cervicore Corpectomy Cage

by Verticor, Ltd.

510(k) K091426

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 NumberK091426 Date23 Dec 2009ClearedStatusActive

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  • Withdrawn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
MQP
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 Cervicore Corpectomy Cage is a spinal vertebral body replacement device, classified under the classification name Spinal Vertebral Body Replacement Device. It is designed to provide structural support and mechanical stability to the spinal column following the resection or excision of cervical vertebrae, often due to trauma, tumor, or degenerative conditions.

Implanted in the operating room by orthopedic surgeons, the Cervicore Corpectomy Cage is intended for use in clinical settings. It is supplied as a single-use device and requires supplemental fixation along with autograft or allograft bone. The device holds FDA 510(k) clearance (K091426) under the Traditional 510(k) review pathway, with a product code of MQP.

Other devices from Verticor, Ltd.

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 is the Cervicore Corpectomy Cage used for in spinal surgery?

    The Cervicore Corpectomy Cage is designed to replace cervical vertebrae that have been removed due to trauma, tumors, or degenerative conditions. It provides structural support and mechanical stability to the spinal column during the recovery process, ensuring proper alignment and load distribution after the resection.

  • Is the Cervicore Corpectomy Cage intended for single-use or can it be reused?

    The Cervicore Corpectomy Cage is explicitly supplied as a single-use device. This design ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks.

  • How is the Cervicore Corpectomy Cage implanted, and what additional materials are required?

    The device is implanted in the operating room by orthopedic surgeons following cervical vertebral resection. It requires supplemental fixation (e.g., screws or plates) and is paired with autograft or allograft bone to promote fusion and stability.

  • What regulatory pathway was followed for FDA clearance of the Cervicore Corpectomy Cage?

    The Cervicore Corpectomy Cage received FDA clearance under the Traditional 510(k) review pathway, specifically through the Orthopedic (OR) advisory committee. It was determined to be substantially equivalent to a predicate device, with clearance granted on December 23, 2009, under the product code MQP.