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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2018-09-07 under 510(k) 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. The listed applicant is Paragon 28, Inc.. The 510(k) number is K182148.

When did SILVERBACK Gorilla Plating System receive FDA 510(k) clearance?

SILVERBACK Gorilla Plating System received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182148.

Who is the listed applicant for SILVERBACK Gorilla Plating System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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