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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 ROAD
UNIT 3E
OXFORD,  CT  06478
Applicant Contact RICHARD DESLAURIERS
Correspondent
QUALGENIX
1 JACK'S HILL ROAD
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
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