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. |
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Trade Name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
Classification Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde |
Generic Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
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HDE Number | H020008 |
Supplement Number | S007 |
Date Received | 09/16/2005 |
Decision Date | 11/30/2005 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for removal of the sterile bowl and spatula accessory components from the final packaged product. |
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