Dynanail Mini Hybrid
K-Number: K203381 · 2021-01-15
ApplicantMedShape, Inc.
Decision Date2021-01-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Dynanail Mini Hybrid is a medical device manufactured by MedShape, Inc.. It received FDA 510(k) clearance on 2021-01-15 under approval number K203381. 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 Dynanail Mini Hybrid?
Dynanail Mini Hybrid is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by MedShape, Inc.. The 510(k) number is K203381.
When was Dynanail Mini Hybrid approved by the FDA?
Dynanail Mini Hybrid received FDA 510(k) clearance on 2021-01-15, under approval number K203381.
What company makes Dynanail Mini Hybrid?
Dynanail Mini Hybrid is manufactured by MedShape, Inc..
What is the FDA product code for Dynanail Mini Hybrid?
The FDA product code for Dynanail Mini Hybrid 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.