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FDA 510(k)

MULTI-USE COMPRESSION SCREW

K-Number: K043102 · 2005-01-21

ApplicantWrightmedicaltechnologyinc
Decision Date2005-01-21
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MULTI-USE COMPRESSION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K043102. 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 MULTI-USE COMPRESSION SCREW?

MULTI-USE COMPRESSION SCREW is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K043102.

When did MULTI-USE COMPRESSION SCREW receive FDA 510(k) clearance?

MULTI-USE COMPRESSION SCREW received FDA 510(k) clearance on 2005-01-21, under 510(k) number K043102.

Who is the listed applicant for MULTI-USE COMPRESSION SCREW?

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

What is the FDA product code for MULTI-USE COMPRESSION SCREW?

The FDA product code for MULTI-USE COMPRESSION 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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