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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K141941
Device Name SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D
Applicant
Stryker Corporate
Boetzinger St. 41
Freiburg, Baden-Wuerttemberg,  DE 79111
Applicant Contact LILIAN ECKERT
Correspondent
Stryker
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact Becky Ditty
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/17/2014
Decision Date 10/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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