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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 K061577
Device Name OVALTWIST PEDICLE SCREW SYSTEM
Applicant
Signus Medizintechnik GmbH
681 W. 2760 N.
Pleasant Grove,  UT  84062
Applicant Contact MIKE ENSIGN
Correspondent
Signus Medizintechnik GmbH
681 W. 2760 N.
Pleasant Grove,  UT  84062
Correspondent Contact MIKE ENSIGN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received06/07/2006
Decision Date 09/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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