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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 K120275
Device Name SYNTHES ACIS/VERTEBRAL SPACER CR
Applicant
SYNTHES (USA) LLC
1302 wrights lane east
west chester,  PA  19380
Applicant Contact heather guerin
Correspondent
SYNTHES (USA) LLC
1302 wrights lane east
west chester,  PA  19380
Correspondent Contact heather guerin
Regulation Number888.3080
Classification Product Code
ODP  
Date Received01/30/2012
Decision Date 05/25/2012
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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