MINIARS SCREWS
K-Number: K143596 · 2016-02-05
ApplicantOvermed Srl.
Decision Date2016-02-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MINIARS SCREWS is a medical device manufactured by Overmed Srl.. It received FDA 510(k) clearance on 2016-02-05 under approval number K143596. 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 MINIARS SCREWS?
MINIARS SCREWS is a medical device that received FDA 510(k) clearance on 2016-02-05. It is manufactured by Overmed Srl.. The 510(k) number is K143596.
When was MINIARS SCREWS approved by the FDA?
MINIARS SCREWS received FDA 510(k) clearance on 2016-02-05, under approval number K143596.
What company makes MINIARS SCREWS?
MINIARS SCREWS is manufactured by Overmed Srl..
What is the FDA product code for MINIARS SCREWS?
The FDA product code for MINIARS SCREWS 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.