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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 K172674
Device Name Sapphire Cervical Implant System
Applicant
Sapphire Medical Group
32565 B Golden Lantern
#113
Dana Point,  CA  92629
Applicant Contact Anthony Ruggiero
Correspondent
Spineworks, LLC
614 E 3900 S
Salt Lake City,  UT  84107
Correspondent Contact Marshall McCarty
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/05/2017
Decision Date 11/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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