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Locking Cage Full XPE Cup

by United Orthopedic Corporation

510(k) K163441

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163441↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK163441 Date25 Aug 2017ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
LZO
Device class
Class II
Regulation
21 CFR Part 888.3353
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Locking Cage Full XPE Cup is a spinal orthopedic device classified as a spinal fixation device with a locking mechanism, designed to stabilize the lumbar spine. It features an expandable cage filled with XPE (expanded polytetrafluoroethylene) to promote bone ingrowth and enhance spinal fusion outcomes.

This device is intended for surgical use in the orthopedic setting and is supplied sterile for single-use. It is manufactured under FDA 510(k) clearance (K163441) and complies with EU Medical Device Directives (MDD) and the Medical Device Regulation (MDR). The cage is available in a single product code (LZO) and requires proper surgical technique for implantation, adhering to standard orthopedic protocols.

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Questions

AI-generated answers, 18 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 Locking Cage Full XPE Cup primarily used for in spinal surgery?

    The Locking Cage Full XPE Cup is designed to stabilize the lumbar spine by providing structural support during spinal fusion procedures. The expandable cage filled with XPE (expanded polytetrafluoroethylene) promotes bone ingrowth, which helps enhance the success of spinal fusion by encouraging the spine to heal more effectively.

  • Is this device intended for reuse, or is it meant to be used only once?

    The Locking Cage Full XPE Cup is supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and performance.

  • What regulatory pathways has this device followed for approval?

    This device has undergone FDA clearance through a 510(k) submission (K163441) under the traditional review process, with a decision of substantial equivalence in the orthopedic category. It also complies with EU Medical Device Directives (MDD) and the Medical Device Regulation (MDR), ensuring adherence to both U.S. and European regulatory standards.

  • How is the Locking Cage Full XPE Cup supplied, and what should I consider for storage?

    The device is supplied sterile and ready for surgical use. Since it is single-use, it should be stored in its original packaging in a clean, dry environment, protected from contamination and extreme temperatures until use. Always follow the manufacturer’s storage instructions to maintain sterility and integrity.

  • Are there multiple sizes or models available for this Locking Cage Full XPE Cup?

    Currently, the Locking Cage Full XPE Cup is available in a single product code (LZO) and does not appear to offer multiple sizes or models. Selection should be based on standard orthopedic protocols and surgical requirements, ensuring proper fit and function for the intended lumbar spine application.