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FDA 510(k)

CANNULATED SCREW

K-Number: K070617 · 2007-06-14

ApplicantFournitures Hospitalieres Industrie
Decision Date2007-06-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CANNULATED 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 2007-06-14 under 510(k) number K070617. 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 CANNULATED SCREW?

CANNULATED SCREW is a medical device that received FDA 510(k) clearance on 2007-06-14. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K070617.

When did CANNULATED SCREW receive FDA 510(k) clearance?

CANNULATED SCREW received FDA 510(k) clearance on 2007-06-14, under 510(k) number K070617.

Who is the listed applicant for CANNULATED 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 CANNULATED SCREW?

The FDA product code for CANNULATED 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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