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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 K083798
Device Name IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
Applicant
MEDICREA TECHNOLOGIES
111 HILL ROAD
DOUGLASSVILLE,  PA  19518
Applicant Contact DONALD GUTHNER
Correspondent
MEDICREA TECHNOLOGIES
111 HILL ROAD
DOUGLASSVILLE,  PA  19518
Correspondent Contact DONALD GUTHNER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/22/2008
Decision Date 05/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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