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FDA 510(k)

BIO-EUROLIG INTERFERENCE SCREW

K-Number: K031939 · 2004-06-24

ApplicantFournitures Hospitalieres Industrie
Decision Date2004-06-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO-EUROLIG INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2004-06-24 under 510(k) number K031939. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-EUROLIG INTERFERENCE SCREW?

BIO-EUROLIG INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2004-06-24. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K031939.

When did BIO-EUROLIG INTERFERENCE SCREW receive FDA 510(k) clearance?

BIO-EUROLIG INTERFERENCE SCREW received FDA 510(k) clearance on 2004-06-24, under 510(k) number K031939.

Who is the listed applicant for BIO-EUROLIG INTERFERENCE SCREW?

The FDA 510(k) record lists Fournitures Hospitalieres Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-EUROLIG INTERFERENCE SCREW?

The FDA product code for BIO-EUROLIG INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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