Cannulated Compression Device System
K-Number: K210146 · 2022-04-13
Decision Date2022-04-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cannulated Compression Device System is a medical device manufactured by Orthopedic Designs North America, Inc.. It received FDA 510(k) clearance on 2022-04-13 under approval number K210146. 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 Cannulated Compression Device System?
Cannulated Compression Device System is a medical device that received FDA 510(k) clearance on 2022-04-13. It is manufactured by Orthopedic Designs North America, Inc.. The 510(k) number is K210146.
When was Cannulated Compression Device System approved by the FDA?
Cannulated Compression Device System received FDA 510(k) clearance on 2022-04-13, under approval number K210146.
What company makes Cannulated Compression Device System?
Cannulated Compression Device System is manufactured by Orthopedic Designs North America, Inc..
What is the FDA product code for Cannulated Compression Device System?
The FDA product code for Cannulated Compression Device System is HWC. This falls under the Cardiovascular category.
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Official Source
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