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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 K952167
Device Name IMZ BONE TACK SYSTEM
Applicant
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact DAVID BALDING
Correspondent
Interpore Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact DAVID BALDING
Regulation Number872.4880
Classification Product Code
DZL  
Date Received05/08/1995
Decision Date 11/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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