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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 K181231
Device Name DePuy Synthes T-PAL Spacer System
Applicant
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Heta Shah
Correspondent
DePuy Synthes
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Rozanne Shirley
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/09/2018
Decision Date 12/06/2018
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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