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FDA 510(k)

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM

K-Number: K121417 · 2012-07-18

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

Device Summary

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL 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 2012-07-18 under 510(k) number K121417. 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 XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM?

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM 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 K121417.

When did XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM receive FDA 510(k) clearance?

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM received FDA 510(k) clearance on 2012-07-18, under 510(k) number K121417.

Who is the listed applicant for XMCP, HALLUX, TARSX, EXTREMITY MEDICAL 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 XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM?

The FDA product code for XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM 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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