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CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

by Medos International SARL

510(k) K191212

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K191212↗

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 NumberK191212 Date24 Sep 2019ClearedStatusActive
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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PGM
Device Class
Class II
Regulation
21 CFR Part 888.3070
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 EXPEDIUM, VIPER, TiMX, CrossOver, E-Z Link, and related spine systems are orthopedic implants designed for spinal stabilization and fixation. These devices include screws, cross connectors, and modular components for use in thoracolumbar, lumbar, and sacral-alar-iliac applications, providing structural support to the spine during surgical interventions.

These systems are intended for single-use and are supplied sterile, with components available in various sizes and configurations to accommodate different anatomical requirements. The devices are classified as Class II medical devices under FDA regulations and comply with the Medical Device Regulation (MDR). They are used in operating rooms and require proper handling and storage as per manufacturer guidelines to maintain sterility and functionality.

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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.

  • Are these spine systems designed for reuse in multiple surgeries, or are they intended for single-use only?

    These systems, including the EXPEDIUM, VIPER, TiMX, and related spine systems, are explicitly designed for single-use only. The manufacturer emphasizes that components are supplied sterile and must be handled and stored according to guidelines to maintain sterility and functionality, which is only feasible for one-time surgical use.

  • What types of spinal applications are these connectors and screws intended for, and how do they differ from one another?

    These systems are engineered for spinal stabilization and fixation across multiple regions, including thoracolumbar, lumbar, and sacral-alar-iliac (SAI) applications. For example, the VIPER SAI system is specifically designed for sacral-alar-iliac fixation, while the EXPEDIUM Fenestrated Screw System and VIPER Fenestrated Screws accommodate broader anatomical variations. The modular components—such as screws, cross connectors, and fenestrated designs—allow customization for different surgical needs, ensuring compatibility with diverse patient anatomies.

  • How should these devices be stored to ensure they remain sterile and functional until use?

    The manufacturer recommends storing these single-use, sterile spine systems in their original packaging as per provided guidelines to preserve sterility and functionality. Improper handling or exposure to contaminants could compromise the devices, so adherence to storage instructions is critical. The systems are intended for use in operating rooms, where controlled environments further support their integrity.

  • What regulatory pathways have these spine systems undergone, and what does that mean for their use?

    These devices have undergone FDA 510(k) clearance and comply with the Medical Device Regulation (MDR) in the EU, confirming they meet established safety and performance standards. The classification as Class II medical devices under FDA regulations indicates they are subject to stricter controls than Class I but are not considered high-risk like Class III. This means they are approved for clinical use in spinal stabilization procedures after demonstrating substantial equivalence to predicate devices.