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Bio-Eurolig Interference Screw

by Fournitures Hospitalieres Industrie

510(k) K031939

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 NumberK031939 Date24 Jun 2004ClearedStatusActive

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  • Withdrawn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
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bio-Eurolig Interference Screw is a bone fixation screw used to provide interference fixations of bone-tendon-bone and soft tissue grafts in ACL reconstruction. It is used in orthopedic procedures, specifically in arthroscopy. The device is classified as a screw, fixation, bone. The Bio-Eurolig Interference Screw is a medical device used in orthopedic applications.

The Bio-Eurolig Interference Screw is supplied by Fournitures Hospitalieres Industrie and has a product code of HWC. It has been cleared with a decision code of SESE, indicating substantial equivalence. The device has an FDA 510K clearance, with the clearance number K031939. The screw is used in orthopedic settings, specifically for ACL reconstruction through arthroscopy or other methods.

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Questions

AI-generated answers, 1 Oct 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 Bio-Eurolig Interference Screw used for?

    The Bio-Eurolig Interference Screw is used to provide interference fixations of bone-tendon-bone and soft tissue grafts in ACL reconstruction orthopedic procedures, specifically in arthroscopy.

  • Is the Bio-Eurolig Interference Screw supplied sterile?

    The description does not specify if the Bio-Eurolig Interference Screw is supplied sterile, but it is used in orthopedic settings where sterility is typically required.

  • What is the regulatory status of the Bio-Eurolig Interference Screw?

    The Bio-Eurolig Interference Screw has been cleared with an FDA 510K clearance, with the clearance number K031939, indicating substantial equivalence.

  • What type of fixation does the Bio-Eurolig Interference Screw provide?

    The Bio-Eurolig Interference Screw provides interference fixation of bone-tendon-bone and soft tissue grafts.