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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 K162986
Device Name SPIRA Open Matrix ALIF
Applicant
CAMBER SPINE TECHNOLOGIES
418 E. Lancaster Avenue
Wayne,  PA  19087
Applicant Contact Michael Black
Correspondent
MCRA,LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/27/2016
Decision Date 06/12/2017
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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