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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 south st
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS006
Date Received08/29/2005
Decision Date10/26/2007
Product Code
OJZ
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 the use of vdmax for quarterly sterilization audits and narrowing of certain of the acceptance criteria for release of bone powder and collagen matrix.
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