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FDA 510(k)

EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM

K-Number: K082934 · 2009-04-23

ApplicantExtremity Medical, LLC
Decision Date2009-04-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2009-04-23 under 510(k) number K082934. 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 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM?

EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-23. The listed applicant is Extremity Medical, LLC. The 510(k) number is K082934.

When did EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM receive FDA 510(k) clearance?

EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM received FDA 510(k) clearance on 2009-04-23, under 510(k) number K082934.

Who is the listed applicant for EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM?

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

What is the FDA product code for EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM?

The FDA product code for EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Extremity Medical, LLC as applicant

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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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