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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K181639
Device Name Panta 2 Arthrodesis Nail System
Applicant
Integra LifeSciences Corporation
11101 Metric Blvd.
Austin,  TX  78758
Applicant Contact Blesson Abraham
Correspondent
Integra LifeSciences Corporation
11101 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Blesson Abraham
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/21/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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