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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 K120203
Device Name TM-400 DEVICE
Applicant
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received01/23/2012
Decision Date 06/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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