FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K131459 |
AAP IMPLANTATE AG |
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE |
10/17/2013 |
K083144 |
ACUMED LLC |
ACUMED CLAVICLE SCREW SYSTEM |
06/16/2009 |
K980788 |
ALPHATEC MFG., INC. |
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM |
05/22/1998 |
K981716 |
AVANTA ORTHOPAEDICS, INC. |
EXTERNAL FIXATION |
07/17/1998 |
K974911 |
AVANTA ORTHOPAEDICS, INC. |
EXTERNAL FIXATOR |
03/16/1998 |
K003294 |
BIOMET, INC. |
BIOMET LATERAL TROCH PLATE |
11/03/2000 |
K003131 |
BIOMET, INC. |
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT |
11/02/2000 |
K021182 |
BIOMET, INC. |
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR |
05/13/2002 |
K011137 |
BIOMET, INC. |
RESORBABLE HAMMERTOE PIN |
06/19/2001 |
K130298 |
BIOPRO, INC. |
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM |
06/18/2013 |
K061599 |
BK MEDITECH CO., LTD. |
PIN SCREW |
07/26/2006 |
K990353 |
BREGMA INTERNATIONAL TRADING COMPANY LTD. |
STAINLESS STEEL FIXATION PINS |
06/01/1999 |
K150661 |
CITIEFFE s.r.l |
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite |
07/07/2015 |
K103001 |
DEPUY ORTHOPAEDICS, INC. |
ROCKWOOD CLAVICLE PINS |
02/17/2011 |
K963973 |
DEPUY, INC. |
DEPUY CANNULATED CROSS PIN SCREW SYSTEM |
12/16/1996 |
K991649 |
DEPUY, INC. |
DEPUY ROCKWOOD CLAVICLE PIN |
07/14/1999 |
K192768 |
EiserTech, LLC |
Temporary Fixation Pins |
12/26/2019 |
K140875 |
GENOSSIS, LLC |
OPTOSSOL COMPRESSION DEVICE SYSTEM |
05/30/2014 |
K992970 |
HAND BIOMECHANICS LAB, INC. |
DIGIT WIDGET |
11/08/1999 |
K982068 |
HOWMEDICA CORP. |
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM |
08/31/1998 |
K001886 |
HOWMEDICA OSTEONICS CORP. |
APEX FIXATION PINS |
07/12/2000 |
K011136 |
HOWMEDICA OSTEONICS CORP. |
APEX FIXATION PINS |
05/04/2001 |
K001228 |
IMMEDICA, INC. |
EXTERNAL FIXATION ANCHOR PIN |
07/07/2000 |
K961920 |
MEDICINE LODGE, INC. |
CROSS PIN |
09/17/1996 |
K100414 |
MERETE MEDICAL GMBH |
PROTOE ENDOSORB SMALL HAMMER TOE PIN |
07/02/2010 |
K102777 |
MERETE MEDICAL GMBH |
TWISTCUT ENDOSORB SCREWS |
12/20/2010 |
K061498 |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
ALLOFIX ANCHOR, 5.0 MM ANCHOR |
07/06/2006 |
K011875 |
NEWDEAL S.A. |
MODIFICATION TO THE TAC' PIN |
09/06/2001 |
K993910 |
NEWDEAL S.A. |
TAC' PIN |
02/01/2000 |
K072710 |
NEXA ORTHOPEDICS, INC. |
NEXFIX COMPRESSION PIN |
11/08/2007 |
K051740 |
NEXA ORTHOPEDICS, INC. |
TAPERED COMPRESSION PIN |
09/06/2005 |
K974186 |
ORTHOFIX SRL |
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING |
03/18/1998 |
K955848 |
ORTHOFIX, INC. |
ORTHOFIX MODULSYSTEM |
03/20/1996 |
K963433 |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
THREADED FIXATION PIN |
11/06/1996 |
K964893 |
OSTEONICS CORP. |
HANSSON PIN SYSTEM |
02/28/1997 |
K960023 |
PROMEX, INC. |
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS |
03/18/1996 |
K982931 |
SGARLATO LABORATORIES, INC. |
THREADED FIXATION PIN |
10/21/1998 |
K031154 |
SINTEA BIOTECH, INC. |
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X |
06/24/2003 |
K071540 |
SMALL BONE INNOVATIONS INC. |
SBI TITANIUM THREADED PIN |
08/08/2007 |
K210784 |
Smith & Nephew, Inc. |
Extended HA Half Pins |
04/02/2021 |
K023921 |
SMITH & NEPHEW, INC. |
JET-X HA COATED HALF PINS |
02/05/2003 |
K023134 |
SMITH & NEPHEW, INC. |
JET-X TIN COATED HALF PINS |
10/09/2002 |
K213874 |
Smith & Nephew, Inc. |
MAVERICK External Fixation System |
02/11/2022 |
K223112 |
Smith & Nephew, Inc. |
MAVERICK Mini External Fixation System |
12/08/2022 |
K033289 |
SMITH & NEPHEW, INC. |
MODIFICATION TO JET-X HA COATED HALF PINS |
01/13/2004 |
K994143 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] |
02/18/2000 |
K120871 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION |
06/07/2012 |
K970713 |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
COMPASS UNIVERSAL HINGE |
04/03/1997 |
K970751 |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
HEIDELBERG EXTERNAL FIXATOR |
04/16/1997 |
K012270 |
Stryker Endoscopy |
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM |
09/28/2001 |
K020097 |
Stryker Endoscopy |
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM |
03/15/2002 |
K011319 |
Stryker Endoscopy |
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX |
07/20/2001 |
K211508 |
Stryker GmbH |
Steinmann Pins and Kirschner Wires |
10/05/2021 |
K061493 |
STRYKER HOWMEDICA OSTEONICS |
APEX PINS |
07/07/2006 |
K182171 |
Summit MedVentures |
SMV Scientific K-Wire and Pins |
10/25/2018 |
K983757 |
SYNTEC SCIENTIFIC CORP. |
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01 |
12/04/1998 |
K200933 |
Syntec Scientific Corporation |
Syntec Non-Sterile Steinmann Pins System |
05/05/2020 |
K002605 |
SYNTHES (USA) |
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW |
11/20/2000 |
K970097 |
SYNTHES (USA) |
PROXIMAL FEMORAL NAIL (PFN) SYSTEM |
03/13/1997 |
K040765 |
SYNTHES (USA) |
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS |
04/12/2004 |
K001720 |
SYNTHES (USA) |
SYNTHES SACRAL BAR SYSTEM |
08/24/2000 |
K030336 |
TELEFLEX MEDICAL GROUP |
KMEDIC EXTERNAL FIXATION DEVICES |
03/06/2003 |
K191803 |
Tinavi (Anhui) Medical Technologies Co., Ltd. |
Orthopedic Fixation Pin |
04/14/2020 |
K053513 |
UNION SURGICAL LLC |
T-PIN |
01/13/2006 |
K032532 |
UNION SURGICAL LLC |
TARAS THREADED FIXATION PIN |
10/22/2003 |
K163487 |
Vilex in Tennessee, Inc |
Ultima HA Coated Half Pins and Wire |
02/13/2017 |
K132820 |
VILEX, INC. |
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES |
07/23/2014 |
K955780 |
ZIMMER, INC. |
RIGIDYNE A EXTERNAL FIXATION SYSTEM |
02/09/1996 |