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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K992369
Device Name SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact LYNN M RODARTI
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact LYNN M RODARTI
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received07/15/1999
Decision Date 10/13/1999
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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