MICATM Screw System
K-Number: K162353 · 2017-04-13
ApplicantWrightmedicaltechnologyinc
Decision Date2017-04-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MICATM Screw System is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-04-13 under approval number K162353. 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 MICATM Screw System?
MICATM Screw System is a medical device that received FDA 510(k) clearance on 2017-04-13. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K162353.
When was MICATM Screw System approved by the FDA?
MICATM Screw System received FDA 510(k) clearance on 2017-04-13, under approval number K162353.
What company makes MICATM Screw System?
MICATM Screw System is manufactured by Wrightmedicaltechnologyinc.
What is the FDA product code for MICATM Screw System?
The FDA product code for MICATM 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.