SILVERBACK Gorilla Plating System
K-Number: K182148 · 2018-09-07
ApplicantParagon 28, Inc.
Decision Date2018-09-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SILVERBACK Gorilla Plating System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2018-09-07 under approval number K182148. 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 SILVERBACK Gorilla Plating System?
SILVERBACK Gorilla Plating System is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Paragon 28, Inc.. The 510(k) number is K182148.
When was SILVERBACK Gorilla Plating System approved by the FDA?
SILVERBACK Gorilla Plating System received FDA 510(k) clearance on 2018-09-07, under approval number K182148.
What company makes SILVERBACK Gorilla Plating System?
SILVERBACK Gorilla Plating System is manufactured by Paragon 28, Inc..
What is the FDA product code for SILVERBACK Gorilla Plating System?
The FDA product code for SILVERBACK Gorilla Plating System is HWC. This falls under the Cardiovascular category.
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Official Source
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