ChM 4.5mm Cortical screws
K-Number: K210490 · 2021-10-05
ApplicantChm Sp. Z O.O.
Decision Date2021-10-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ChM 4.5mm Cortical screws is a medical device manufactured by Chm Sp. Z O.O.. It received FDA 510(k) clearance on 2021-10-05 under approval number K210490. 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 ChM 4.5mm Cortical screws?
ChM 4.5mm Cortical screws is a medical device that received FDA 510(k) clearance on 2021-10-05. It is manufactured by Chm Sp. Z O.O.. The 510(k) number is K210490.
When was ChM 4.5mm Cortical screws approved by the FDA?
ChM 4.5mm Cortical screws received FDA 510(k) clearance on 2021-10-05, under approval number K210490.
What company makes ChM 4.5mm Cortical screws?
ChM 4.5mm Cortical screws is manufactured by Chm Sp. Z O.O..
What is the FDA product code for ChM 4.5mm Cortical screws?
The FDA product code for ChM 4.5mm Cortical 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.