FDA 510(k) Applications for Medical Device Product Code "DZL"
(Screw, Fixation, Intraosseous)
| 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 |
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