FDA 510(k) Applications for Medical Device Product Code "HBF"
(Drills, Burrs, Trephines & Accessories (Compound, Powered))

FDA 510(k) Number Applicant Device Name Decision Date
K833266 ACRA CUT, INC. ACRA-CUT 12/29/1983
K032970 ACRA CUT, INC. ACRA-CUT XPRESS 120 12/08/2003
K892866 ACRA CUT, INC. AUTOMATIC CRANIAL DRILL (PERFORATOR) 06/15/1989
K121253 ADEOR MEDICAL TECHNOLOGIES GMBH MERIDIAN CRANIAL PERFORATOR 07/17/2012
K820087 CODMAN & SHURTLEFF, INC. CODMAN * REUSABLE PERFORATOR 02/04/1982
K073336 Codman & Shurtleff, Inc. CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 01/04/2008
K071931 Codman & Shurtleff, Inc. CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 10/22/2007
K924242 CODMAN & SHURTLEFF, INC. DISPOSABLE PERFORATOR 07/08/1993
K933894 CODMAN & SHURTLEFF, INC. DISPOSABLE PERFORATOR 12/10/1993
K791101 CODMAN & SHURTLEFF, INC. DISPOSABLE PERFORATORS, JACOBS, HUDSON 08/28/1979
K141455 MICROMAR IND. COM. LTD. EASYDRILL AUTOSTOP CRANIAL PERFORATOR 03/16/2015
K875019 NEURODYNAMICS, INC. GHAJAR GUIDE SYSTEM FOR THE PERFORATOR 01/22/1988
K082010 STRYKER IRELAND LTD., INSTRUMENTS DIVISION STRYKER DISPOSABLE CRANIAL PERFORATOR BIT 12/29/2008
K982991 THE ANSPACH EFFORT, INC. ANSPACH ACCESS CRANIAL PERFORATOR 10/21/1998
K082637 THE ANSPACH EFFORT, INC. CRANIAL PERFORATOR 12/22/2008


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