DynaNail Mini
K-Number: K182677 · 2019-02-14
ApplicantMedShape, Inc.
Decision Date2019-02-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DynaNail Mini is a medical device manufactured by MedShape, Inc.. It received FDA 510(k) clearance on 2019-02-14 under approval number K182677. 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?
DynaNail Mini is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by MedShape, Inc.. The 510(k) number is K182677.
When was DynaNail Mini approved by the FDA?
DynaNail Mini received FDA 510(k) clearance on 2019-02-14, under approval number K182677.
What company makes DynaNail Mini?
DynaNail Mini is manufactured by MedShape, Inc..
What is the FDA product code for DynaNail Mini?
The FDA product code for DynaNail Mini 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.