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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, Cervical
510(k) Number K112801
Device Name AYERS ROCK CERVICAL CAGE
Applicant
Qualgenix
1 Jack'S Hill Rd.
Unit 3e
Oxford,  CT  06478
Applicant Contact RICHARD DESLAURIERS
Correspondent
Qualgenix
1 Jack'S Hill Rd.
Unit 3e
Oxford,  CT  06478
Correspondent Contact RICHARD DESLAURIERS
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/27/2011
Decision Date 05/01/2012
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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