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PEEK Spinal Infusion Cage

by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

510(k) K223776

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 NumberK223776 Date3 Mar 2023ClearedStatusActive

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Peek Spinal Infusion Cage is an intervertebral fusion device with bone graft designed for lumbar applications. It functions to provide spinal stability during surgical procedures.

This device is identified by K-number K223776 and has received FDA 510(k) clearance. It is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. and is classified under product code MAX.

Other devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

See all devices from Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. →

Questions

AI-generated answers, 22 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 primary function of the PEEK Spinal Infusion Cage?

    This device is an intervertebral fusion device designed specifically for lumbar applications. It is used during surgical procedures to provide necessary spinal stability by incorporating bone graft.

  • What is the regulatory status of this device?

    The PEEK Spinal Infusion Cage has received FDA 510(k) clearance under K-number K223776. It has been determined to be substantially equivalent to predicate devices for its intended use in spinal surgery.

  • Who is the manufacturer of this spinal fusion device?

    The device is manufactured by Changzhou Geasure Medical Apparatus and Instruments Co., Ltd., located in the West Taihu Science and Technology Industrial Park in Changzhou, China.