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FDA 510(k)

PROSTEP TBC Implant System

K-Number: K183620 · 2019-06-06

ApplicantWrightmedicaltechnologyinc
Decision Date2019-06-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROSTEP TBC Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-06-06 under 510(k) number K183620. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTEP TBC Implant System?

PROSTEP TBC Implant System is a medical device that received FDA 510(k) clearance on 2019-06-06. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K183620.

When did PROSTEP TBC Implant System receive FDA 510(k) clearance?

PROSTEP TBC Implant System received FDA 510(k) clearance on 2019-06-06, under 510(k) number K183620.

Who is the listed applicant for PROSTEP TBC Implant 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 PROSTEP TBC Implant System?

The FDA product code for PROSTEP TBC Implant System is HRS.

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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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