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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K112809
Device Name BLUE MOUNTAIN CERVICAL PLATE
Applicant
Qualgenix, LLC
1 Jack'S Hill Rd.
Unit 3e
Oxford,  CT  06478
Applicant Contact RICHARD DESLAURIERS
Correspondent
Qualgenix, LLC
1 Jack'S Hill Rd.
Unit 3e
Oxford,  CT  06478
Correspondent Contact RICHARD DESLAURIERS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/27/2011
Decision Date 06/20/2012
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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