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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 Integrated Fixation, Lumbar
510(k) Number K173432
Device Name ENZA-A Titanium ALIF
Applicant
Camber Spine Technologies
418 E. Lancaster Ave.
Wayne,  PA  19087
Applicant Contact Damian Heinz
Correspondent
RQMIS, Inc.
110 Haverhill Rd., Suite 526
Amesbury,  MA  01913
Correspondent Contact Paul Speidel
Regulation Number888.3080
Classification Product Code
OVD  
Date Received11/02/2017
Decision Date 04/18/2018
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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