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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameOP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
Applicant
OLYMPUS BIOTECH CORPORATION
35 south st
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS009
Date Received05/26/2006
Decision Date09/15/2009
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for a manufacturing site located at stryker biotech, 9 technology drive, west lebanon, new hampshire 03784 to increase the capacity to manufacture bulk op-i protein and op- i bone powder.
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