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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 K122845
Device Name ES2 SPINAL SYSTEM MODEL 48280XXXX
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact SORAYA KING
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact SORAYA KING
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received09/17/2012
Decision Date 12/07/2012
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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