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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
Smith & Nephew, Inc.
7135 goodlett farms parkway
cordova, TN 38016
HDE NumberH010005
Date Received12/26/2001
Decision Date03/22/2002
Product Code
OMX[ Registered Establishments with OMX ]
Docket Number 02M-0121
Advisory Committee Orthopedic
Supplement Typehde original
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 OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
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