FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K063769 |
ALPHA-BIO TEC LTD |
ALPHA BIO BONE FIXATION SCREW SYSTEM |
03/30/2007 |
K973056 |
BICON, INC. |
BONE GRAFT SCREW SYSTEM |
11/12/1997 |
K011675 |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
THE AUTOTAC SYSTEM |
06/22/2001 |
K993493 |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
THE AUTOTAC SYSTEM |
01/07/2000 |
K022790 |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
THE AUTOTAC SYSTEM TITANIUM TACK |
08/28/2002 |
K140908 |
BIOMET SPORTS MEDICINE |
JUGGERKNOT MINI SOFT ANCHOR |
10/02/2014 |
K981666 |
BIOMET, INC. |
2.5 MM LACTOSORB SCREWS |
11/03/1998 |
K002423 |
BIOMET, INC. |
LACTOSORB PUSH SCREW |
10/20/2000 |
K981459 |
BIOMET, INC. |
MEMBRANE TACK |
07/14/1998 |
K012908 |
BIOPLATE, INC. |
BIOPLATE RESORBABLE BONE SCREW |
11/28/2001 |
K974392 |
BIOVISION GMBH |
LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM |
01/30/1998 |
K955140 |
BRASSELER USA I, L.P. |
2.0 X 6MM SCREW |
01/05/1996 |
K222367 |
Dentis Co., Ltd. |
SAVE GBR |
03/23/2023 |
K974817 |
DOCTOR'S RESEARCH GROUP, INC. |
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM |
03/13/1998 |
K981881 |
DOCTOR'S RESEARCH GROUP, INC. |
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING |
12/02/1998 |
K151540 |
ELI-KA TECHNOLOGIES |
MC BIO Supertack Tack 3mm, 4mm and 5mm |
05/26/2016 |
K132212 |
HAGER & MEISINGER GMBH |
DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL |
02/14/2014 |
K130682 |
HAGER & MEISINGER GMBH |
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT |
08/13/2013 |
K201210 |
Hager & Meisinger GmbH |
The Micro Screw System, Micro Screw System Basic |
10/08/2021 |
K972480 |
IMPLANT INNOVATIONS, INC. |
3I BIORESORBABLE FIXATION TACK |
12/23/1997 |
K982951 |
IMTEC CORP. |
IMTEC BIOPIN |
06/21/1999 |
K973180 |
IMTEC CORP. |
IMTEC BONE TAC |
11/18/1997 |
K960945 |
INTERPORE INTL. |
IMZ MEMBRANE TACK SYSTEM |
05/24/1996 |
K171831 |
Intra-Lock International, Inc. |
Intra-Lock Bone Fixation System |
10/26/2017 |
K101902 |
JEIL MEDICAL CORPORATION |
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 |
02/08/2011 |
K103084 |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
NEODENT GRAFT SCREW |
02/14/2011 |
K982927 |
KINAMED, INC. |
QUICK TAP SELF DRILLING SCREW |
09/08/1998 |
K083432 |
KLS MARTIN L.P. |
DRILL FREE MMF SCREW |
03/31/2009 |
K042573 |
KLS-MARTIN L.P. |
KLS MARTIN DRILL-FREE MMF SCREW |
10/18/2004 |
K980760 |
KLS-MARTIN L.P. |
KLS-MARTIN MMF SCREW |
12/21/1999 |
K092855 |
MILTEX, INC. |
MILTEX MEMBRANE TACK KIT |
12/29/2009 |
K992623 |
MITEK PRODUCTS |
MITEK MINI ANCHOR |
11/02/1999 |
K993575 |
MITEK PRODUCTS |
RESOLVE QUICKANCHOR |
12/29/1999 |
K993327 |
MITEK PRODUCTS |
TALON ANCHOR SNAP-PAK |
12/16/1999 |
K160991 |
NEOBIOTECH CO., LTD. |
Neo GBR System |
01/10/2017 |
K201561 |
Neoss Limited |
Membrane Screws and Membrane Tacks |
10/05/2020 |
K182881 |
Osstem Implant Co., Ltd. |
Bone Screw, Bone Tack |
08/09/2019 |
K181854 |
Osstem Implant Co., Ltd.. |
OssBuilder System |
05/07/2019 |
K093719 |
OSTEOGENICS BIOMEDICAL, INC. |
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# |
03/01/2010 |
K151195 |
OSTEOMED |
OsteoMed IMF Screw |
09/21/2015 |
K012486 |
OSTEOMED CORP. |
OSTEOMED BIORESORBABLE FIXATION SYSTEM |
01/16/2002 |
K961418 |
OSTEOMED CORP. |
OSTEOMED MSS |
10/25/1996 |
K962774 |
OSTEOMED CORP. |
OSTEOMED QUICKFIX |
10/10/1997 |
K161857 |
Salvin Dental Specialties |
Salvin Tenting Screw System |
04/28/2017 |
K100182 |
SALVIN DENTAL SPECIALTIES, INC. |
SALVIN DENTAL SPECIALTIES FIXATION SCREW |
05/10/2010 |
K073342 |
SALVIN DENTAL SPECIALTIES, INC. |
SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW |
03/26/2008 |
K080430 |
STORZ AM MARK GMBH |
STOMA BONE BLOCK SCREW |
11/21/2008 |
K051871 |
STORZ AM MARK GMBH |
STOMA BONE SCREW |
10/27/2005 |
K050515 |
STRAUMANN USA, INC. |
BONE BLOCK FIXATION SET |
04/05/2005 |
K050535 |
STRYKER INSTRUMENTS |
STRYKER MMF SCREW |
03/17/2005 |
K231599 |
Stryker Leibinger GmbH & Co. KG |
Stryker MP, Mandible, HMMF and MMF AXS Screws |
08/24/2023 |
K093464 |
SYNTHES (USA) |
RAPIDSORB PLUS SCREW SYSTEM |
01/25/2010 |
K964261 |
SYNTHES (USA) |
SMF STAINLESS STEEL BONE SCREWS |
04/11/1997 |
K963546 |
SYNTHES (USA) |
SMF TITANIUM (TI) ALLOY BONE SCREWS |
06/24/1997 |
K041887 |
SYNTHES (USA) |
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS |
08/19/2004 |
K021850 |
SYNTHES (USA) |
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS |
06/10/2002 |
K981362 |
SYNTHES (USA) |
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR |
06/29/1998 |
K010527 |
SYNTHES (USA) |
SYNTHES (USA) IMF SCREWS |
04/25/2001 |
K050606 |
SYNTHES (USA) |
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) |
04/06/2005 |
K983485 |
SYNTHES (USA) |
SYNTHES 1.3 MM SELF-DRILLING SCREW |
12/21/1998 |
K002935 |
SYNTHES (USA) |
SYNTHES 1.5MM TI BROW LIFT SCREW |
11/16/2000 |
K980199 |
SYNTHES (USA) |
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS |
04/17/1998 |
K031807 |
SYNTHES (USA) |
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS |
07/02/2003 |
K010690 |
SYNTHES (USA) |
SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR |
05/18/2001 |
K955369 |
THE STRAUMANN CO. |
MEMFIX |
01/23/1996 |
K021522 |
WALTER LORENZ SURGICAL, INC. |
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW |
05/21/2002 |
K983728 |
WALTER LORENZ SURGICAL, INC. |
LORENZ IMF SCREW |
05/13/1999 |