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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K103320
Device Name SYNTHES XRL
Applicant
Synthes Spine Co.Lp
1302 Wrights Ln. E.
West Chester,  PA  19380
Applicant Contact HEATHER GUERIN
Correspondent
Synthes Spine Co.Lp
1302 Wrights Ln. E.
West Chester,  PA  19380
Correspondent Contact HEATHER GUERIN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received11/12/2010
Decision Date 10/20/2011
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
Recalls CDRH Recalls
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