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 a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-11-16 under approval 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. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K212996.
When was Sterile PHALINX Hammertoe System approved by the FDA?
Sterile PHALINX Hammertoe System received FDA 510(k) clearance on 2021-11-16, under approval number K212996.
What company makes Sterile PHALINX Hammertoe System?
Sterile PHALINX Hammertoe System is manufactured by Wrightmedicaltechnologyinc.
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.