Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NamePROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT
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 blvd.
austin, TX 78758
HDE NumberH980002
Supplement NumberS002
Date Received03/27/2001
Decision Date05/30/2001
Product Code
MPK[ Registered Establishments with MPK ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
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".
-
-