Data / Medical devices / Costa Rica / Medtronic Medical Costa Rica S.R.L.
Medtronic Medical Costa Rica S.R.L.: FDA-registered device maker in Coyol Alajuela, Costa Rica, 143 510(k) clearances
Medtronic Medical Costa Rica S.R.L. is registered with the FDA (registration 3014725904) in Coyol Alajuela, Costa Rica. It lists 33 device types. The FDA files 143 510(k) clearances under its listings, the newest dated May 25, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014725904
- Address
- Coyol Free Zone Bldg B7 Multitenant 7-8, Module F, Coyol Alajuela, Costa Rica, 20113
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- March 23, 2005
- Registered through
- 2027
- Brand names listed
- ARTHROSCOPE, Atlantis Translational Plate, Atlantis Vision Anterior Cervical, Atlas Cable, BIT DRILLS, Bone Graft Washer, CAPSTONE PTC SPINAL SYSTEM, CCD Spine System 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. Newest 100 of 143.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 25, 2022 | K221244 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 24, 2021 | K210425 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 30, 2021 | K210637 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| January 15, 2021 | K203678 | CD HORIZON Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 8, 2020 | K202328 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 19, 2020 | K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | PML | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 4, 2019 | K183197 | PYRAMESH Implant System | MQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182928 | CD Horizon Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 29, 2018 | K182119 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 18, 2018 | K180851 | VERTEX Reconstruction System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 8, 2018 | K173249 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 19, 2017 | K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 21, 2017 | K163375 | INFINITY OCT System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 20, 2016 | K163301 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 16, 2016 | K162379 | CD HORIZON® Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 12, 2016 | K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | OUR | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| January 6, 2016 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | PML | Substantially Equivalent | Medtronic Sofamor Danek USA, Incorporated | accessdata.fda.gov |
| November 13, 2015 | K152277 | PIVOX(tm) Oblique Lateral Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 11, 2015 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 9, 2015 | K142559 | ELEVATE Spinal System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 25, 2015 | K150200 | CD HORIZON Growth Rod Conversion Set | PGM | Substantially Equivalent | Medtronic Sofamor Danek USA, Incorporated | accessdata.fda.gov |
| February 13, 2015 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143569 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 11, 2015 | K150178 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 6, 2015 | K143471 | VERTEX Reconstruction System | NKG | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 4, 2014 | K141632 | ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 1, 2014 | K143141 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 1, 2014 | K142591 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 27, 2014 | K142847 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danck USA, Inc. | accessdata.fda.gov |
| October 21, 2014 | K141604 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 9, 2014 | K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| December 6, 2013 | K132328 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 25, 2013 | K132639 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 8, 2013 | K132471 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 6, 2013 | K132111 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| June 5, 2013 | K131321 | CD HORIZON SPINAL SYSTEM | OSH | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| April 10, 2013 | K130646 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 1, 2013 | K123906 | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 25, 2013 | K123656 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 3, 2012 | K122862 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 5, 2012 | K121680 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 21, 2011 | K113174 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 4, 2011 | K110063 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| August 30, 2011 | K111942 | TSRH SPINAL SYSTEMS | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 23, 2010 | K103049 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 17, 2010 | K102555 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 30, 2010 | K101772 | TSRH(R) SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 22, 2010 | K101074 | MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 15, 2009 | K092325 | MODIFICATION TO:CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 17, 2009 | K091813 | INTREPID SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 26, 2009 | K093058 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| October 2, 2009 | K092676 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 2, 2009 | K091974 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 14, 2009 | K090740 | MODIFICATION TO: TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 6, 2009 | K091365 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Soafamor Danek | accessdata.fda.gov |
| May 15, 2009 | K090390 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 17, 2009 | K090714 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| January 16, 2009 | K082728 | VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 14, 2008 | K083071 | VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 30, 2008 | K080429 | MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 18, 2008 | K080805 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 11, 2007 | K071942 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 1, 2007 | K071416 | PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 28, 2007 | K072429 | MODIFICATION TO TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| September 18, 2007 | K072317 | MODIFICATION TO:TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 14, 2007 | K070742 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| February 23, 2007 | K063100 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE | KWQ | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| November 6, 2006 | K063083 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| August 11, 2006 | K061579 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| May 25, 2006 | K061274 | VENTURE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| January 6, 2006 | K053474 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| January 5, 2006 | K053483 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 28, 2005 | K052747 | MODIFICATION TO:CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 21, 2005 | K052734 | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| September 23, 2005 | K052402 | VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| September 23, 2005 | K052376 | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 31, 2005 | K052144 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 22, 2005 | K052187 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 16, 2005 | K052054 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 6, 2005 | K050082 | CENTERPIECE PLATE FIXATION SYSTEM | NQW | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| April 11, 2005 | K043053 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 24, 2005 | K050439 | CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| March 21, 2005 | K043488 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| February 23, 2005 | K043602 | QUADRANT RETRACTOR SYSTEM | GAD | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| February 18, 2005 | K050282 | MODIFICATION TO TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 21, 2004 | K042789 | VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 14, 2004 | K042962 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 19, 2004 | K042922 | VENTURE ANTERIOR CERVICAL PLATING SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| October 8, 2004 | K042524 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 7, 2004 | K042453 | MODIFICATION TO EQUATION FIXATION SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| August 25, 2004 | K042025 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| June 10, 2004 | K041282 | MODIFICATION TO TSRH SPINAL SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| May 14, 2004 | K040962 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| March 31, 2004 | K040583 | MODIFICATION TO: CD HORIZON SPINAL SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| September 17, 2003 | K032578 | TSRH SPINAL SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 4, 2003 | K032037 | CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) | MNI | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 11, 2003 | K032265 | CD HORIZON SPINAL SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 27, 2003 | K031888 | MODIFICATION TO CD HORIZON SPINAL SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 27, 2003 | K031655 | CD HORIZON SPINAL SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
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Updated May 25, 2022. 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.