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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K113219
Device Name ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Applicant
Ellipse Technologies, Inc.
13900 Alton Pkwy. Suite 123
Irvine,  CA  92618
Applicant Contact JOHN MCLNTYRE
Correspondent
Ellipse Technologies, Inc.
13900 Alton Pkwy. Suite 123
Irvine,  CA  92618
Correspondent Contact JOHN MCLNTYRE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/01/2011
Decision Date 10/19/2012
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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