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FDA 510(k)

TekBrace Solo Soft Tissue Reinforcement Device

K-Number: K261621 · 2026-06-09

ApplicantTheramicro
Decision Date2026-06-09
Product CodeQUW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TekBrace Solo Soft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Theramicro. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K261621. 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 2026-06-09. The listed applicant is Theramicro. The 510(k) number is K261621.

When did TekBrace Solo Soft Tissue Reinforcement Device receive FDA 510(k) clearance?

TekBrace Solo Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2026-06-09, under 510(k) number K261621.

Who is the listed applicant for TekBrace Solo Soft Tissue Reinforcement Device?

The FDA 510(k) record lists Theramicro as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Theramicro as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QUW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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