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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 integrated fixation, cervical
510(k) Number K111439
Device Name CHESAPEAKE (CERVICAL COMPONENTS)
Applicant
K2M, INC.
751 MILLER DR.,SE
LEESBURG,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2M, INC.
751 MILLER DR.,SE
LEESBURG,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3080
Classification Product Code
OVE  
Date Received05/24/2011
Decision Date 08/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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