Data / Medical devices / United States / Theramicro

Theramicro: FDA-registered device maker in Cordova, TN, United States, 5 510(k) clearances

Name: Theramicro FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Theramicro is registered with the FDA (registration 3032412536) in Cordova, TN, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3032412536
Address: 51 Germantown Ct Ste 200, Cordova, TN, United States, 38018
Owner or operator: Theramicro (10093892)
Roles: Repackager or relabeler, Specification developer
First device listed: July 30, 2025
Registered through: 2026
Brand names listed: TeKBrace Solo Soft Tissue Reinforcement Device, TeKForce All Suture Anchor, TeKForce Knotless Syndesmosis Implant, TekBrace, TekBrace Kit, TekBrace Solo Soft Tissue Reinforcement Device

Devices it lists

Device	Product code	Class	Role	Source
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	OWX	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	QUW	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Specification developer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 9, 2026	K261621	TekBrace Solo Soft Tissue Reinforcement Device	QUW	Substantially Equivalent	Theramicro	accessdata.fda.gov
March 6, 2026	K253538	TeKBrace Knotless Anchor	MBI	Substantially Equivalent	Theramicro	accessdata.fda.gov
May 30, 2025	K251063	TekBrace Solo Soft Tissue Reinforcement Device	QUW	Substantially Equivalent	Theramicro	accessdata.fda.gov
November 1, 2024	K242311	EXPERT - Flexible Joint Fixation System	HTN	Substantially Equivalent	GM Dos Reis Industria e Comercio Ltda.	accessdata.fda.gov
August 2, 2023	K223114	Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors	MBI	Substantially Equivalent	Gm Dos Reis Industria E Comerico Ltda.	accessdata.fda.gov

Compare with other makers

Updated June 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.