TeKBrace Knotless Anchor
K-Number: K253538 · 2026-03-06
ApplicantTheramicro
Decision Date2026-03-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TeKBrace Knotless Anchor is a medical device manufactured by Theramicro. It received FDA 510(k) clearance on 2026-03-06 under approval number K253538. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TeKBrace Knotless Anchor?
TeKBrace Knotless Anchor is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by Theramicro. The 510(k) number is K253538.
When was TeKBrace Knotless Anchor approved by the FDA?
TeKBrace Knotless Anchor received FDA 510(k) clearance on 2026-03-06, under approval number K253538.
What company makes TeKBrace Knotless Anchor?
TeKBrace Knotless Anchor is manufactured by Theramicro.
What is the FDA product code for TeKBrace Knotless Anchor?
The FDA product code for TeKBrace Knotless Anchor is MBI.
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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.