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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 K180724
Device Name SPIRA Open Matrix LLIF
Applicant
Camber Spine Technologies, LLC
418 E. Lancaster Ave.
Wayne,  PA  19087
Applicant Contact Sean S. Bishop
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Barry Sands
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/20/2018
Decision Date 06/25/2018
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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