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FDA 510(k)

PROSTEP MICA Screw System

K-Number: K181377 · 2019-01-11

ApplicantWrightmedicaltechnologyinc
Decision Date2019-01-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROSTEP MICA Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K181377. 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 MICA Screw System?

PROSTEP MICA Screw System is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K181377.

When did PROSTEP MICA Screw System receive FDA 510(k) clearance?

PROSTEP MICA Screw System received FDA 510(k) clearance on 2019-01-11, under 510(k) number K181377.

Who is the listed applicant for PROSTEP MICA Screw 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 MICA Screw System?

The FDA product code for PROSTEP MICA 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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