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 Name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
|
HDE Number | H020008 |
Supplement Number | S009 |
Date Received | 05/26/2006 |
Decision Date | 09/15/2009 |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a manufacturing site located at stryker biotech, 9 technology drive, west lebanon, new hampshire 03784 to increase the capacity to manufacture bulk op-i protein and op- i bone powder. |
|
|