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FDA 510(k)

EPIPHYSIS SCREW

K-Number: K043410 · 2005-02-24

ApplicantI.T.S. Implantat-Technologie-Systeme GmbH
Decision Date2005-02-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPIPHYSIS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. It received FDA 510(k) clearance on 2005-02-24 under 510(k) number K043410. 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 EPIPHYSIS SCREW?

EPIPHYSIS SCREW is a medical device that received FDA 510(k) clearance on 2005-02-24. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. The 510(k) number is K043410.

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

EPIPHYSIS SCREW received FDA 510(k) clearance on 2005-02-24, under 510(k) number K043410.

Who is the listed applicant for EPIPHYSIS SCREW?

The FDA 510(k) record lists I.T.S. Implantat-Technologie-Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIPHYSIS SCREW?

The FDA product code for EPIPHYSIS 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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