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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 K181337
Device Name Sypher Spacer System
Applicant
Biogennix, LLC
18007 Sky Park Cir., Suite F
Irvine,  CA  92614
Applicant Contact Tim Bumbalough
Correspondent
Jalex Medical, LLC
30311 Clemens Rd. Suite 5d
Westlake,  OH  44145
Correspondent Contact Daniel Johnson
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received05/21/2018
Decision Date 09/18/2018
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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