Skip to content

VIPER PRIME Screws with Fenestrations

by Medos International SARL EUDAMED510(k)

Active European Union and United States

510(k) K170543

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK170543 Date4 May 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

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  • Withdrawn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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
NKB
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 Viper Prime Screws with Fenestrations are orthopedic spinal fixation devices designed for use in posterior spinal constructs. These screws are intended to provide immobilization and stabilization of spinal segments when integrated with existing components of the Viper System, facilitating structural support during spinal surgery.

These screws are supplied as single-use, non-sterile devices and require sterilization prior to use. They are classified under product code NKB and are authorized under FDA 510(k) clearance (K170543) and the EU Medical Device Regulation (MDR). Sizes and configurations are specified in the device specifications, and proper handling, storage, and sterilization procedures must be followed as per manufacturer guidelines.

Other devices from Medos International SARL

See all devices from Medos International SARL →

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 screws meant for anterior or posterior spinal fixation, and how do they work with the Viper System?

    The Viper Prime Screws with Fenestrations are specifically designed for posterior spinal fixation. They provide immobilization and stabilization of spinal segments when used alongside other components of the Viper System, offering structural support during spinal surgery. The fenestrations allow for bone growth through the screw, enhancing integration with the spine.

  • Are these screws single-use or reusable, and what sterilization process is required before use?

    These screws are single-use only and are supplied in a non-sterile state. They must be sterilized prior to use following the manufacturer’s guidelines to ensure safety and efficacy. Proper sterilization is critical before implantation to maintain device integrity and prevent infection.

  • What regulatory pathways have been followed for this device, and which advisory committee was involved?

    The Viper Prime Screws with Fenestrations have undergone FDA 510(k) clearance (K170543) under the Traditional pathway, with a decision of Substantially Equivalent (SESE). The review was conducted by the Orthopedic (OR) Advisory Committee. Additionally, the device complies with the EU Medical Device Regulation (MDR).

  • How are these screws stored, and are there specific handling instructions I should follow?

    While exact storage conditions are detailed in the manufacturer’s guidelines, these screws are non-sterile and must be stored in a clean, dry environment to prevent contamination. Since they require sterilization before use, proper packaging integrity must be maintained until sterilization is completed. Always follow Medos International’s instructions to avoid damage or compromise of the device.