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FDA 510(k)

5TH METATARSAL FRACTURE SCREW

K-Number: K053136 · 2006-01-05

ApplicantWrightmedicaltechnologyinc
Decision Date2006-01-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

5TH METATARSAL FRACTURE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2006-01-05 under 510(k) number K053136. 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 5TH METATARSAL FRACTURE SCREW?

5TH METATARSAL FRACTURE SCREW is a medical device that received FDA 510(k) clearance on 2006-01-05. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K053136.

When did 5TH METATARSAL FRACTURE SCREW receive FDA 510(k) clearance?

5TH METATARSAL FRACTURE SCREW received FDA 510(k) clearance on 2006-01-05, under 510(k) number K053136.

Who is the listed applicant for 5TH METATARSAL FRACTURE 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 5TH METATARSAL FRACTURE SCREW?

The FDA product code for 5TH METATARSAL FRACTURE 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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