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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K061813
Device Name MANTIS SPINAL SYSTEM
Applicant
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact SIMONA VOIC
Correspondent
Stryker Spine
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact SIMONA VOIC
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
MNI   NKB  
Date Received06/27/2006
Decision Date 09/19/2006
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
Recalls CDRH Recalls
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