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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 s. st.
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS011
Date Received04/02/2007
Decision Date06/16/2008
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 changes to the collagen identification process in the collagen matrix in both the op-i implant and op-i putty.
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