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FDA 510(k)

Sterile PHALINX Hammertoe System

K-Number: K212996 · 2021-11-16

ApplicantWrightmedicaltechnologyinc
Decision Date2021-11-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sterile PHALINX Hammertoe System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-11-16 under 510(k) number K212996. 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 Sterile PHALINX Hammertoe System?

Sterile PHALINX Hammertoe System is a medical device that received FDA 510(k) clearance on 2021-11-16. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K212996.

When did Sterile PHALINX Hammertoe System receive FDA 510(k) clearance?

Sterile PHALINX Hammertoe System received FDA 510(k) clearance on 2021-11-16, under 510(k) number K212996.

Who is the listed applicant for Sterile PHALINX Hammertoe System?

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 Sterile PHALINX Hammertoe System?

The FDA product code for Sterile PHALINX Hammertoe 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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