FDA 510(k) Application Details - K133363

Device Classification Name

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510(K) Number K133363
Device Name INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
Applicant LDR SPINE, USA, INC.
4628 NORTHPARK DRIVE
COLORADO SPRING, CO 80918 US
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Contact MEREDITH MAY
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Regulation Number

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Classification Product Code PEK
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Date Received 11/01/2013
Decision Date 03/07/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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