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 |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
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HDE Number | H020008 |
Supplement Number | S005 |
Date Received | 08/24/2005 |
Decision Date | 05/02/2008 |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for changes in the bioburden tests performed on the bone powder, collagen matrix and pre-irradiated op-i implant, and the deletion of the bioburden resistancespecification for the collagen matrix. |
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