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Rectangular Corpectomy Cage

by Amendia, Inc.

510(k) K152460

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 NumberK152460 Date22 Dec 2015ClearedStatusActive

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  • Withdrawn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, 25 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 Rectangular Corpectomy Cage is a vertebral body replacement system designed to replace a resected or excised vertebral body due to tumor or trauma/fracture. It is intended for use as a vertebral body replacement in the thoracolumbar spine, spanning from T1 to L5.

The device is supplied as a single-use implant and is intended for use with supplemental fixation. It is cleared through the FDA 510(k) pathway under product code MQP, classified as a Class 2 Orthopedic device. The device is manufactured by Amendia, Inc. and is not MRI safe.

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