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 | S012 |
Date Received | 08/17/2007 |
Decision Date | 04/17/2008 |
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 the following manufacturing changes: i) elimination of ethanol as a processing solvent (47. 5% (v/v) etoh/0. 01 % tea (trifluoroacetic) replaced with 0. 01% (v/v) tfa); 2) change in op-i solution concentration from 0. 37-0. 4lmg/ml op-i to 0. 68-0. 72 op-1; 3) sequential powder (collagen matrix) and liquid (op- i solution) fill into each vial of op-1 implant 4) modified container closure system to address increased capacity/scalability, easier opening, and increased availability; 5) release specification change by altering in vitro biologic activity assay to improve accuracy and robustness; and 6) modified package insert to include changes to instructions for use to address modified container closure mechanism. The devices, as modified, will be marketed under the trade names op-i implant and op- i puttyand are indicated for recalcitrant tibia fractures and posterolateral fusion revision of failed posterolateral fusion surgeries of the lumbar spine, respectively. |
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