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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 NumberS014
Date Received06/30/2009
Decision Date02/24/2011
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for:1) an alternate collagen matrix manufacturing facility within the existing building 3 on thewest lebanon, nh campus;2) minor collagen matrix manufacturing process changes to accommodate a new suite andequipment;3) an alternate collagen matrix container closure;4) collagen matrix release specification changes; and5) use of both tibia and femur bones as starting material for the manufacture of the raw material for collagen matrix component.
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