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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOP-1 IMPLANT
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunion
Applicant
OLYMPUS BIOTECH CORPORATION
35 south st
hopkinton, MA 01748
HDE NumberH010002
Date Received05/29/2001
Decision Date10/17/2001
Product Code
OKD
Docket Number 01M-0482
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductYes
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S021 S022 S023 S024 S025 S026 S027 S030 S031 
S032 S033 
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