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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 NumberS015
Date Received12/03/2009
Decision Date06/11/2010
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 a change to the quarterly auditing of the terminal sterilization process for the putty additive component of op- 1 putty. The device, as modified, will be marketed under the trade name op- i putty and is indicated for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbarspinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion.
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