FDA 510(k)

PROSTEP TBI (Tailors Bunion Implant) System

K-Number: K190970 · 2019-08-13

Decision Date2019-08-13

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PROSTEP TBI (Tailors Bunion Implant) System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-08-13 under approval number K190970. 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 PROSTEP TBI (Tailors Bunion Implant) System?

PROSTEP TBI (Tailors Bunion Implant) System is a medical device that received FDA 510(k) clearance on 2019-08-13. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K190970.

When was PROSTEP TBI (Tailors Bunion Implant) System approved by the FDA?

PROSTEP TBI (Tailors Bunion Implant) System received FDA 510(k) clearance on 2019-08-13, under approval number K190970.

What company makes PROSTEP TBI (Tailors Bunion Implant) System?

PROSTEP TBI (Tailors Bunion Implant) System is manufactured by Wrightmedicaltechnologyinc.

What is the FDA product code for PROSTEP TBI (Tailors Bunion Implant) System?

The FDA product code for PROSTEP TBI (Tailors Bunion Implant) System is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.