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FDA 510(k)

CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER

K-Number: K070525 · 2007-03-29

ApplicantWrightmedicaltechnologyinc
Decision Date2007-03-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2007-03-29 under 510(k) number K070525. 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 CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER?

CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER is a medical device that received FDA 510(k) clearance on 2007-03-29. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K070525.

When did CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER receive FDA 510(k) clearance?

CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER received FDA 510(k) clearance on 2007-03-29, under 510(k) number K070525.

Who is the listed applicant for CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER?

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 CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER?

The FDA product code for CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER is HWC. This falls under the Cardiovascular category.

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Official Source

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

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