Inion CompressOn Screw
K-Number: K203105 · 2021-01-13
ApplicantInion OY
Decision Date2021-01-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Inion CompressOn Screw is a medical device manufactured by Inion OY. It received FDA 510(k) clearance on 2021-01-13 under approval number K203105. 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 Inion CompressOn Screw?
Inion CompressOn Screw is a medical device that received FDA 510(k) clearance on 2021-01-13. It is manufactured by Inion OY. The 510(k) number is K203105.
When was Inion CompressOn Screw approved by the FDA?
Inion CompressOn Screw received FDA 510(k) clearance on 2021-01-13, under approval number K203105.
What company makes Inion CompressOn Screw?
Inion CompressOn Screw is manufactured by Inion OY.
What is the FDA product code for Inion CompressOn Screw?
The FDA product code for Inion CompressOn Screw 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.