FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K112111 |
ACUMED LLC |
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR |
11/14/2011 |
K212990 |
Acumed LLC |
Acumed Ankle Syndesmosis Repair System |
01/07/2022 |
K130986 |
ACUMED LLC |
FRAG-LOC SYSTEM |
07/23/2013 |
K965028 |
ACUMED, INC. |
ACUMED SUTURE WASHER |
03/17/1997 |
K954148 |
ACUMED, INC. |
SUTURE WASHER |
01/17/1996 |
K162805 |
Akros Medical |
Akros Fibulink Syndesmosis Repair Kit |
01/10/2017 |
K173550 |
Akros Medical |
Akros FibuLinkÖ Syndesmosis Repair Kit |
12/14/2017 |
K200361 |
Akros Medical |
Akros Scruture Anchor LisFranc Repair Kit |
04/06/2020 |
K221485 |
Arthrex Inc. |
Arthrex FiberTape and TigerTape Cerclage Sutures |
08/22/2022 |
K232755 |
Arthrex Inc. |
Arthrex FiberTape and TigerTape Cerclage Sutures |
10/06/2023 |
K220947 |
Arthrex Inc. |
Arthrex Knotless AC Repair Devices |
06/06/2022 |
K213644 |
Arthrex Inc. |
Arthrex Knotless Mini TightRopes |
12/17/2021 |
K201522 |
Arthrex Inc. |
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System |
09/03/2020 |
K112437 |
ARTHREX, INC. |
ARTHREX FRACTURE SYSTEM |
12/21/2011 |
K023119 |
ARTHREX, INC. |
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B |
12/18/2002 |
K043145 |
ARTHREX, INC. |
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B |
02/18/2005 |
K140328 |
ARTHREX, INC. |
CMC MINI TIGHTROPE |
03/10/2014 |
K133275 |
ARTHREX, INC. |
MINI TIGHTROPE |
01/30/2014 |
K090107 |
ARTHREX, INC. |
MINI TIGHTROPE |
08/06/2009 |
K071978 |
ARTHREX, INC. |
MINI TIGHTROPE FT REPAIR KIT |
08/15/2007 |
K061925 |
ARTHREX, INC. |
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS |
10/31/2006 |
K052776 |
ARTHREX, INC. |
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD |
12/13/2005 |
K043248 |
ARTHREX, INC. |
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS |
02/16/2005 |
K170440 |
Arthrosurface, Inc |
KISSloc Suture System |
05/03/2017 |
K133835 |
ARTHROSURFACE, INC. |
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM |
07/03/2014 |
K141219 |
BIOMET MANUFACTURING CORP. |
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS |
07/18/2014 |
K132510 |
BIOPRO, INC. |
BIOPRO - INFINITY PLATE ANCHOR SYSTEM |
10/24/2013 |
K190516 |
CONMED Corporation |
MicroLink All-Suture Button Fixation System (Radiolucent) |
06/28/2019 |
K190582 |
CONMED Corporation |
MicroLink All-Suture Button Fixation System (Radiopaque) |
06/28/2019 |
K153211 |
CORACOID SOLUTIONS, INC. |
M-Fix Acromioclavicular Device |
02/02/2016 |
K190143 |
Corin USA |
LARS AC Band Device |
11/04/2019 |
K183094 |
Cycla Orthopedics Ltd |
CyclaPlex Correction System |
04/26/2019 |
K131850 |
DALLEN MEDICAL, INC. |
TENSYN BAND |
11/15/2013 |
K133858 |
DALLEN MEDICAL, INC. |
TENSYN BAND |
02/28/2014 |
K141264 |
DALLEN MEDICAL, INC. |
TENSYN BAND, TENSYN FRACTURE PLATES |
08/21/2014 |
K143092 |
DALLEN MEDICAL, INC. |
Tensyn Plug |
02/11/2015 |
K150359 |
DALLEN MEDICAL, INC. |
Tensyn Plug |
05/07/2015 |
K983265 |
DEPUY ACE MEDICAL CO. |
DEPUY ACE COMPOSITE LOCKING NUT |
10/26/1998 |
K983906 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY ORTHOTECH SPIKED WASHER |
12/18/1998 |
K991135 |
DEPUY, INC. |
SOFT TISSUE SUTURE WASHER |
04/29/1999 |
K200332 |
GM dos Reis Industria e Comercio Ltda |
EXPERT - Joint Fixation System |
10/29/2020 |
K220260 |
In2Bones USA, LLC |
Hercules Syndesmosis Implant System |
03/31/2022 |
K111032 |
INSTRATEK, INC. |
CMC CABLE FIX |
08/31/2011 |
K082384 |
INSTRATEK, INC. |
HAV-LOK BUNION CORRECTION SYSTEM |
12/08/2008 |
K091763 |
INSTRATEK, INC. |
MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 |
08/14/2009 |
K954682 |
LINVATEC CORP. |
WASHER, BOLT, NUT, ORTHOPEDIC |
02/09/1996 |
K211612 |
Medline Industries, Inc. |
Medline UNITE REFLEX Dynamic Discs |
12/10/2021 |
K141420 |
MEDSHAPE, INC |
FASTFORWARD |
12/18/2014 |
K172620 |
Mortise Medical LLC |
SyndesMetrics Syndesmosis Repair System |
11/08/2017 |
K132733 |
ORTHOHELIX SURGICAL DESIGNS, INC. |
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES |
01/03/2014 |
K963420 |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
CANCELLOUS SCREW WASHER |
11/15/1996 |
K030619 |
ORTHOPEDIC DESIGNS, INC. |
ODI 7.0MM CANNULATED SCREW SYSTEM |
04/01/2003 |
K171703 |
Panther Orthopedics, Inc. |
PUMA System |
03/01/2018 |
K003496 |
PIONEER SURGICAL TECHNOLOGY |
CANNULATED SCREW SYSTEM |
02/08/2001 |
K992617 |
PIONEER SURGICAL TECHNOLOGY |
HEX BUTTON |
10/27/1999 |
K043411 |
RESOFIX, INC. |
RESOFIX BIOABSORBABLE EXPANSION BOLT |
02/17/2005 |
K082095 |
SMITH & NEPHEW ENDOSCOPY, INC. |
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE |
10/21/2008 |
K162996 |
SMITH & NEPHEW, INC. |
INVISIKNOT Ankle Syndesmosis Repair Kit |
06/08/2017 |
K183232 |
Smith and Nephew, Inc. |
Double ENDOBUTTON Fixation Device |
03/12/2019 |
K982354 |
SPECIAL DEVICES, INC. |
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M |
11/23/1998 |
K091207 |
SURGICRAFT LTD. |
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE |
02/15/2011 |
K011583 |
SYNTHES (USA) |
SPIKED WASHER |
01/30/2002 |
K013806 |
SYNTHES (USA) |
SYNTHES METALLIC SPIKED WASHERS |
02/08/2002 |
K980944 |
SYNTHES (USA) |
SYNTHES SCHUHLI IMPLANT SYSTEM |
04/27/1998 |
K040250 |
TRIAGE MEDICAL INC |
BONE-LOK HP WASHER |
03/23/2004 |
K220650 |
TriMed, Inc. |
TriMed Ripcord Device |
06/01/2022 |
K170249 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GRAVITYÖ Syndesmosis LP |
06/30/2017 |
K180243 |
Xiros Ltd |
Infinity-Lock Button System |
04/03/2018 |
K091799 |
ZIMMER, INC. |
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON |
09/11/2009 |