Tyber Medical Trauma Screw
K-Number: K252901 · 2025-12-31
ApplicantTyber Medical, LLC
Decision Date2025-12-31
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tyber Medical Trauma Screw is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-12-31 under approval number K252901. 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 Screw?
Tyber Medical Trauma Screw is a medical device that received FDA 510(k) clearance on 2025-12-31. It is manufactured by Tyber Medical, LLC. The 510(k) number is K252901.
When was Tyber Medical Trauma Screw approved by the FDA?
Tyber Medical Trauma Screw received FDA 510(k) clearance on 2025-12-31, under approval number K252901.
What company makes Tyber Medical Trauma Screw?
Tyber Medical Trauma Screw is manufactured by Tyber Medical, LLC.
What is the FDA product code for Tyber Medical Trauma Screw?
The FDA product code for Tyber Medical Trauma Screw 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.