Tyber Medical Trauma Screws
K-Number: K192975 · 2020-01-09
ApplicantTyber Medical, LLC
Decision Date2020-01-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tyber Medical Trauma Screws is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2020-01-09 under approval number K192975. 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 Tyber Medical Trauma Screws?
Tyber Medical Trauma Screws is a medical device that received FDA 510(k) clearance on 2020-01-09. It is manufactured by Tyber Medical, LLC. The 510(k) number is K192975.
When was Tyber Medical Trauma Screws approved by the FDA?
Tyber Medical Trauma Screws received FDA 510(k) clearance on 2020-01-09, under approval number K192975.
What company makes Tyber Medical Trauma Screws?
Tyber Medical Trauma Screws is manufactured by Tyber Medical, LLC.
What is the FDA product code for Tyber Medical Trauma Screws?
The FDA product code for Tyber Medical Trauma Screws 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.