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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 | S005 |
Date Received | 04/01/2016 |
Decision Date | 06/14/2016 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Changes to the device labeling and a trade name change. |