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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 K113561
Device Name TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
Applicant
ZIMMER TRABECULAR METAL TECHNOLOGY
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Applicant Contact JUDITH ROSEN
Correspondent
ZIMMER TRABECULAR METAL TECHNOLOGY
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Correspondent Contact JUDITH ROSEN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/01/2011
Decision Date 05/29/2012
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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