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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Rib Replacement
510(k) Number K142587
Device Name Vertical Expandable Prosthetic Titanium Rib
Applicant
Depuy Synthes Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Catherine Kilshaw
Correspondent
Depuy Synthes Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Catherine Kilshaw
Regulation Number888.3070
Classification Product Code
MDI  
Date Received09/15/2014
Decision Date 11/18/2014
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
Recalls CDRH Recalls
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