|
Trade Name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
|
HDE Number | H020008 |
Supplement Number | S011 |
Date Received | 04/02/2007 |
Decision Date | 06/16/2008 |
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 to the collagen identification process in the collagen matrix in both the op-i implant and op-i putty. |