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FDA 510(k)

MODIFICATION TO THE I.C.O.S SCREW

K-Number: K011821 · 2001-09-06

ApplicantNew Deal, S.A.
Decision Date2001-09-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THE I.C.O.S SCREW is the device name listed in this FDA 510(k) record. The listed applicant is New Deal, S.A.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K011821. 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 MODIFICATION TO THE I.C.O.S SCREW?

MODIFICATION TO THE I.C.O.S SCREW is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is New Deal, S.A.. The 510(k) number is K011821.

When did MODIFICATION TO THE I.C.O.S SCREW receive FDA 510(k) clearance?

MODIFICATION TO THE I.C.O.S SCREW received FDA 510(k) clearance on 2001-09-06, under 510(k) number K011821.

Who is the listed applicant for MODIFICATION TO THE I.C.O.S SCREW?

The FDA 510(k) record lists New Deal, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO THE I.C.O.S SCREW?

The FDA product code for MODIFICATION TO THE I.C.O.S 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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