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FDA 510(k)

CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003

K-Number: K043583 · 2005-01-26

ApplicantWrightmedicaltechnologyinc
Decision Date2005-01-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2005-01-26 under 510(k) number K043583. 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 SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003?

CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 is a medical device that received FDA 510(k) clearance on 2005-01-26. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K043583.

When did CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 receive FDA 510(k) clearance?

CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 received FDA 510(k) clearance on 2005-01-26, under 510(k) number K043583.

Who is the listed applicant for CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003?

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 SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003?

The FDA product code for CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 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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