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FDA 510(k)

IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER

K-Number: K121349 · 2012-07-18

ApplicantExtremity Medical, LLC
Decision Date2012-07-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER 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 2012-07-18 under 510(k) number K121349. 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 IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER?

IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER is a medical device that received FDA 510(k) clearance on 2012-07-18. The listed applicant is Extremity Medical, LLC. The 510(k) number is K121349.

When did IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER receive FDA 510(k) clearance?

IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER received FDA 510(k) clearance on 2012-07-18, under 510(k) number K121349.

Who is the listed applicant for IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER?

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 IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER?

The FDA product code for IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER 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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