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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.
 
Trade NameASCENSION PIP
Classification Namehigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis
Generic Namehigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis
Applicant
ASCENSION ORTHOPEDICS, INC.
8700 cameron rd
austin, TX 78754
HDE NumberH010005
Date Received12/26/2001
Decision Date03/22/2002
Product Code
OMX
Docket Number 02M-0121
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
This device is indicated for use in arthroplasty of the proximal interphalangeal (pip) joint when the patient has soft tissue and bone that can provide adequate stabilization and fixation under high demand loading conditions after reconstruction; and needs a revision of a failed pip prosthesis, or has pain, limited motion, or joint subluxation/dislocation secondary to damage or destruction of the articular cartilage.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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