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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K202528
Device Name Cannulated Power Driver Attachment
Applicant
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Megan Callanan
Correspondent
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact Megan Callanan
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/01/2020
Decision Date 10/26/2020
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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