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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, threaded
510(k) Number K061498
Device Name ALLOFIX ANCHOR, 5.0 MM ANCHOR
Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Applicant Contact NANCY L BENNEWITZ
Correspondent
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 MAY STREET
EDISON,  NJ  08837
Correspondent Contact NANCY L BENNEWITZ
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Code
MAI  
Date Received05/31/2006
Decision Date 07/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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