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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 K101997
Device Name ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Applicant
Ellipse Technologies, Inc.
13844 Alton Pkwy., Suite 130
Irvine,  CA  92618
Applicant Contact John McIntyre
Correspondent
Ellipse Technologies, Inc.
13844 Alton Pkwy., Suite 130
Irvine,  CA  92618
Correspondent Contact John McIntyre
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/15/2010
Decision Date 07/12/2011
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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