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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, Cervical
510(k) Number K111983
Device Name VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
Applicant
ZIMMER TRABECULAR METAL TECHNOLOGY
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
ZIMMER TRABECULAR METAL TECHNOLOGY
10 POMEROY RD.
PARSIPPANY,  NJ  07054
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received07/12/2011
Decision Date 11/18/2011
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
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