DynaFuse Fixation System
K-Number: K203595 · 2022-01-04
ApplicantMedShape, Inc.
Decision Date2022-01-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DynaFuse Fixation System is a medical device manufactured by MedShape, Inc.. It received FDA 510(k) clearance on 2022-01-04 under approval number K203595. 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 DynaFuse Fixation System?
DynaFuse Fixation System is a medical device that received FDA 510(k) clearance on 2022-01-04. It is manufactured by MedShape, Inc.. The 510(k) number is K203595.
When was DynaFuse Fixation System approved by the FDA?
DynaFuse Fixation System received FDA 510(k) clearance on 2022-01-04, under approval number K203595.
What company makes DynaFuse Fixation System?
DynaFuse Fixation System is manufactured by MedShape, Inc..
What is the FDA product code for DynaFuse Fixation System?
The FDA product code for DynaFuse Fixation System 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.