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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 K130853
Device Name IDYS(TM) C
Applicant
Clariance
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Clariance
1835 Market St., 29th Floor
Philedelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3080
Classification Product Code
ODP  
Date Received03/28/2013
Decision Date 11/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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