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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K251382
Device Name Phoenix Sinus Tarsi Stent System
Applicant
Astra Orthomed, Inc.
330 Franklin Rd. Suite 135a-213
Brentwood,  TN  37027
Applicant Contact Michael Graham
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy.
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/02/2025
Decision Date 08/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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