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 a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-01-11 under approval 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. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K181377.
When was PROSTEP MICA Screw System approved by the FDA?
PROSTEP MICA Screw System received FDA 510(k) clearance on 2019-01-11, under approval number K181377.
What company makes PROSTEP MICA Screw System?
PROSTEP MICA Screw System is manufactured by Wrightmedicaltechnologyinc.
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
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