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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesemi-constrained metal/polymer finger joint prosthesis
Generic Namesemi-constrained metal/polymer finger joint prosthesis
Encore Medical L/P. d/b/a DJO Surgical
9800 metric boulevard
austin, TX 78758
HDE NumberH980002
Date Received04/08/1998
Decision Date09/28/1998
Product Code
MPK[ Registered Establishments with MPK ]
Docket Number 98M-0895
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
For use in arthroplasty of the pip joint when either the (1) patient is in need of a revision of failed pip prosthesis(es) or (2) patient expect 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009