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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K250769
Device Name Dakota LP System
Applicant
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact Michael Dawson
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
KWQ  
Date Received03/13/2025
Decision Date 11/24/2025
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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