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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
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Applicant
Olympus Biotech Corporation
35 s. st.
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS007
Date Received09/16/2005
Decision Date11/30/2005
Product Code
OJZ
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for removal of the sterile bowl and spatula accessory components from the final packaged product.
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