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Trade Name | PROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT |
Classification Name | semi-constrained metal/polymer finger joint prosthesis |
Generic Name | semi-constrained metal/polymer finger joint prosthesis |
Applicant |
Encore Medical L/P. d/b/a DJO Surgical |
9800 metric boulevard |
austin, TX 78758 |
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HDE Number | H980002 |
Supplement Number | S003 |
Date Received | 11/08/2002 |
Decision Date | 12/31/2002 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new manufacturing facility located at rms co. , 8600 evergreen blvd. , minneapolis, minnesota 55433-6036 and a new sterilization facility located at micronet medical, inc. , 1839 buerkle road, st. Paul, mn. |