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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K100089
Device Name SYNTHES T-PAL SPACER
Applicant
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact HEATHER GUERIN
Correspondent
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact HEATHER GUERIN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/12/2010
Decision Date 05/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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