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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 K122801
Device Name PROVIDENCE CERVICAL CAGE
Applicant
PROVIDENCE MEDICAL TECHNOLOGY, INC.
3650 MT Diablo Blvd Ste 104
Lafayette,  CA  94549
Applicant Contact EDWARD LIOU
Correspondent
PROVIDENCE MEDICAL TECHNOLOGY, INC.
3650 MT Diablo Blvd Ste 104
Lafayette,  CA  94549
Correspondent Contact EDWARD LIOU
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/13/2012
Decision Date 05/24/2013
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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