FDA 510(k) Application Details - K251063

Device Classification Name	More FDA Info for this Device
510(K) Number	K251063
Device Name	TekBrace Solo Soft Tissue Reinforcement Device
Applicant	TheraMicro 51 Germantown Court Suite 200 Cordova, TN 38018 US Other 510(k) Applications for this Company
Contact	Christine Scifert Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2025
Decision Date	05/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review