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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K962774
Device Name OSTEOMED QUICKFIX
Applicant
Osteomed Corp.
3150 Premier Dr.
#110
Irving,  TX  75063
Applicant Contact JAMES D LAFFERTY
Correspondent
Osteomed Corp.
3150 Premier Dr.
#110
Irving,  TX  75063
Correspondent Contact JAMES D LAFFERTY
Regulation Number872.4880
Classification Product Code
DZL  
Date Received07/16/1996
Decision Date 10/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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