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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode LOF PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
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Device
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PMA
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BIOMET EBI BONE HEALING SYSTEM EBI, LLC P790002 S036 12/08/2016
BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATO... EBI, LLC P850022 S028 12/08/2016
Cervical-Stim Orthofix, Inc. P030034 S009 12/02/2016
Spinal-Stim Orthofix, Inc. P850007 S035 12/02/2016
BIO OSTEOGEN SYSTEM 204 EBI, LLC P790002 S035 03/07/2016
OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMU... DJO, LLC P910066 S028 02/18/2016
BIOMET EBI BONE HEALING SYSTEM EBI, LLC P790002 S034 01/14/2016
BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATO... EBI, LLC P850022 S027 01/14/2016
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