TekBrace Solo Soft Tissue Reinforcement Device
K-Number: K251063 · 2025-05-30
ApplicantTheramicro
Decision Date2025-05-30
Product CodeQUW
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
TekBrace Solo Soft Tissue Reinforcement Device is a medical device manufactured by Theramicro. It received FDA 510(k) clearance on 2025-05-30 under approval number K251063. The device is classified under product code QUW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TekBrace Solo Soft Tissue Reinforcement Device?
TekBrace Solo Soft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Theramicro. The 510(k) number is K251063.
When was TekBrace Solo Soft Tissue Reinforcement Device approved by the FDA?
TekBrace Solo Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2025-05-30, under approval number K251063.
What company makes TekBrace Solo Soft Tissue Reinforcement Device?
TekBrace Solo Soft Tissue Reinforcement Device is manufactured by Theramicro.
What is the FDA product code for TekBrace Solo Soft Tissue Reinforcement Device?
The FDA product code for TekBrace Solo Soft Tissue Reinforcement Device is QUW.
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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.