Data / Medical devices / Panama / Ortosistemas, S.A.
Ortosistemas, S.A.: FDA-registered device maker in Panama, Panama, 82 510(k) clearances
Ortosistemas, S.A. is registered with the FDA (registration 3012329552) in Panama, Panama. It lists 37 device types. The FDA files 82 510(k) clearances under its listings, the newest dated January 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012329552
- Address
- Calle Elida Diez, Urbanizacion El Carmen. Bella Vista, Panama, Panama, 238-0816
- Owner or operator
- Ortosistemas, S.A. (10083460)
- Roles
- Exporter to the US
- First device listed
- November 22, 2021
- Registered through
- 2026
- Brand names listed
- Arthrex FastThread Interference Screw, Arthrex Low Profile Screws, Arthrex Synergy Vision Endoscopic Imaging System, Bit, Drill, Camera, Surgical And Accessories, Orthopedic manual surgical instrument., Reamer, Table And Attachments, Operating-Room and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2025 | K243008 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 25, 2024 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 29, 2024 | K241235 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 18, 2024 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 2, 2023 | K223284 | SutureLoc Implant | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 5, 2022 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2022 | K221354 | Arthrex SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 7, 2022 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| August 26, 2022 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 6, 2022 | K220947 | Arthrex Knotless AC Repair Devices | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 22, 2021 | K202582 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 16, 2020 | K203180 | Arthrex DynaNite Nitinol Staples | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 17, 2020 | K202444 | Knotless TensionTight Button Implant System | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2020 | K202581 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 27, 2020 | K201132 | Arthrex Compression Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 24, 2020 | K193575 | Arthrex SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2020 | K200068 | Arthrex DynaNite K-Wire | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 11, 2019 | K191226 | Arthrex SwiveLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 19, 2019 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| April 17, 2019 | K183395 | Arthrex 2.5 mm Tenodesis Screw | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 22, 2018 | K180662 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 3, 2018 | K173362 | DSM Biomedical Calcium Phosphate Cement | MQV | Substantially Equivalent | Kensey Nash Corporation Dba Dsm Biomedical | accessdata.fda.gov |
| March 1, 2018 | K173788 | Arthrex Corkscrew FT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 16, 2018 | K173240 | Arthrex PushLock | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 15, 2017 | K170206 | Arthrex FiberTape Cerclage | JDQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 26, 2017 | K171296 | SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153218 | Arthrex Synergy UHD4 System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 20, 2015 | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 7, 2015 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| July 2, 2015 | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 9, 2015 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 16, 2015 | K143614 | Arthrex Low Profile Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 10, 2014 | K140328 | CMC MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K140019 | ARTHREX BIOSUTURE | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133275 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 31, 2013 | K132043 | ARTHREX SPEEDCINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 24, 2013 | K123569 | ANTEGRADE FEMORAL NAIL | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123241 | ARTHREX FRACTURE PLATES | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 2, 2012 | K120148 | AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW | HSB | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| September 25, 2012 | K122374 | ARTHREX SUTURE (UHMWPE) | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 2012 | K121124 | ARTHREX MIXING AND DELIVERY SYSTEM | FMF | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 2, 2011 | K112237 | MICROSUTURE ANCHORS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110123 | PCL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 22, 2010 | K093343 | GRAFTY QUICKSET | MQV | Substantially Equivalent | Graftys | accessdata.fda.gov |
| August 28, 2009 | K091844 | ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2009 | K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 6, 2008 | K080590 | AOS PROXIMAL HUMERAL PLATE | KTW | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| May 2, 2008 | K080065 | OSFERION | MQV | Substantially Equivalent | Olympus Terumo Biomaterials Corporation | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 26, 2007 | K061499 | OSFERION | MQV | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| December 13, 2006 | K063479 | ARTHREX PUSHLOCK | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 29, 2006 | K062747 | ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 3, 2006 | K053543 | ARTHREX ARTHOERESIS IMPLANT | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 3, 2005 | K052736 | ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 27, 2005 | K051726 | ARTHREX TENODESIS FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 27, 2005 | K050259 | ARTHREX BIO-PIN | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 22, 2003 | K032187 | ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2002 | K021434 | ARTHREX FIBERWIRE IN USP SIZES | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 25, 1994 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
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Updated January 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.