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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, Smooth
510(k) Number K043339
Device Name REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG
Applicant
Xtremi-T, LLC
3131 Princeton Pike, Bldg. 5
Suite 200
Lawrenceville,  NJ  08648
Applicant Contact SHAWN T HUXEL
Correspondent
Xtremi-T, LLC
3131 Princeton Pike, Bldg. 5
Suite 200
Lawrenceville,  NJ  08648
Correspondent Contact SHAWN T HUXEL
Regulation Number888.3040
Classification Product Code
HTY  
Date Received12/03/2004
Decision Date 04/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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