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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameSR PIP System
Classification Namesemi-constrained metal/polymer finger joint prosthesis
Generic Namesemi-constrained metal/polymer finger joint prosthesis
Applicant
Encore Medical L/P. d/b/a DJO Surgical
9800 metric boulevard
austin, TX 78758
HDE NumberH980002
Supplement NumberS008
Date Received02/26/2021
Decision Date04/11/2021
Product Code
MPK[ Registered Establishments with MPK ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a manufacturing site located at sterigenics belgium petit rechain s. A. , avenue andre ernst 21verviers liege be, for sterilization procedures.
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