|
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 |
|
HDE Number | H980002 |
Supplement Number | S002 |
Date Received | 03/27/2001 |
Decision Date | 05/30/2001 |
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 Addition of a titanium plasma spray coating to the pip finger joint stem components approved in s001; associated labeling changes to reflect the addition of hte titanium plasma spray coating; and an increase in the broach width and height by 0. 010". |