Tenodesis screw system
K-Number: K151701 · 2016-01-26
ApplicantNormed Medizin-Technik GmbH
Decision Date2016-01-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tenodesis screw system is a medical device manufactured by Normed Medizin-Technik GmbH. It received FDA 510(k) clearance on 2016-01-26 under approval number K151701. 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 Tenodesis screw system?
Tenodesis screw system is a medical device that received FDA 510(k) clearance on 2016-01-26. It is manufactured by Normed Medizin-Technik GmbH. The 510(k) number is K151701.
When was Tenodesis screw system approved by the FDA?
Tenodesis screw system received FDA 510(k) clearance on 2016-01-26, under approval number K151701.
What company makes Tenodesis screw system?
Tenodesis screw system is manufactured by Normed Medizin-Technik GmbH.
What is the FDA product code for Tenodesis screw system?
The FDA product code for Tenodesis screw 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.