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. |
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Trade Name | ASCENSION PIP |
Classification Name | high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis |
Generic Name | high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis |
Applicant |
Smith & Nephew, Inc. |
7135 goodlett farms parkway |
cordova, TN 38016 |
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HDE Number | H010005 |
Date Received | 12/26/2001 |
Decision Date | 03/22/2002 |
Product Code | |
Docket Number | 02M-0121 |
Advisory Committee |
Orthopedic |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
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
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 |
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