FDA 510(k) Application Details - K152370

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K152370
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant Ellipse Technologies Incorporated
13900 Alton Parkway Ste 123
Irvine, CA 92618 US
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Contact John McIntyre
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 08/21/2015
Decision Date 12/22/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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