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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K251436
Device Name Resolve Anterior Cervical Plate System
Applicant
Pioneer Surgical Technology, Inc.
(D.B.A Resolve Surgical Technologies)
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Jaclyn Holli
Correspondent
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact Jaclyn Holli
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/08/2025
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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