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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Gel For Intraoperative Use In Spine Surgery
510(k) Number K253326
Device Name Oxiplex
Applicant
Fziomed, Inc.
231 Bonetti Dr.
San Luis Obispo,  CA  93401
Applicant Contact Paul Mraz
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Lisa Pritchard
Classification Product Code
QVL  
Date Received09/30/2025
Decision Date 05/01/2026
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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