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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(k) Number K132303
Device Name IMPLANET SPINE SYSTEM
Applicant
Implanet, S.A.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Implanet, S.A.
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3070
Classification Product Code
OSH  
Subsequent Product Codes
KWP   MNH   MNI   NKB  
Date Received07/24/2013
Decision Date 10/10/2013
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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