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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K010051
Device Name POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
Applicant
Xiros Plc
28-30 Blenheim Ter.
Leeds,  GB LS2 9HD
Applicant Contact JIM ROWLAND
Correspondent
Xiros Plc
28-30 Blenheim Ter.
Leeds,  GB LS2 9HD
Correspondent Contact JIM ROWLAND
Regulation Number888.3030
Classification Product Code
JDR  
Date Received01/08/2001
Decision Date 07/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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