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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K090506
Device Name MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
Applicant
Integra LifeSciences Corporation
4900 Charlemar Dr., Bldg. A
Cincinnati,  OH  45227
Applicant Contact HELDER A SOUSA
Correspondent
Integra LifeSciences Corporation
4900 Charlemar Dr., Bldg. A
Cincinnati,  OH  45227
Correspondent Contact HELDER A SOUSA
Regulation Number882.4460
Classification Product Code
HBL  
Date Received02/25/2009
Decision Date 04/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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