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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 K190483
Device Name SPIRA Open Matrix ALIF and LLIF
Applicant
Camber Spine Technologies
501 Allendale Rd.
King Of Prussia,  PA  19406
Applicant Contact Erin Kriebel
Correspondent
RQMIS, Inc.
110 Haverhill Rd.
Amesbury,  MA  01913
Correspondent Contact Matthew Carey
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received02/27/2019
Decision Date 09/23/2019
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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