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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K091807
Device Name MEDPOR FIXATION SYSTEM
Applicant
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Applicant Contact JERRI MANN
Correspondent
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Correspondent Contact JERRI MANN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/18/2009
Decision Date 06/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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