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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K102410
Device Name MATRYX INTERFERENCE SCREW (5.0-6.5MM)
Applicant
CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO,  FL  33773 -4908
Applicant Contact ASHLEA BOWEN
Correspondent
CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO,  FL  33773 -4908
Correspondent Contact ASHLEA BOWEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/24/2010
Decision Date 12/21/2010
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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