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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 | S001 |
Date Received | 02/26/1999 |
Decision Date | 08/26/1999 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a line extension of the a vanta pip prosthesis. The avanta pip joint prosthesis is indicated for use in arthroplasty of the pip joint when either the:patient is in need of a revision of failed pip prosthesis(es); or patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic pip joint. |