Data / Medical devices / United States / Medtronic Puerto Rico Operations Co., Humacao
Medtronic Puerto Rico Operations Co., Humacao: FDA-registered device maker in Humacao, PR, United States, 224 510(k) clearances and 2 PMA approvals
Medtronic Puerto Rico Operations Co., Humacao is registered with the FDA (registration 2647346) in Humacao, PR, United States. It lists 45 device types. The FDA files 224 510(k) clearances and 2 PMA approvals under its listings, the newest dated April 21, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2647346
- Address
- Road 909, KM. 0.4. Barrio Mariana, Humacao, PR, United States, 00792
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- December 12, 1992
- Registered through
- 2027
- Brand names listed
- ACPii Atlantis Cervial Plate, ANTERIOR CERVICAL PLATE SYSTEM, ARTHROSCOPE, ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System, ATLANTIS- Anterior Cervical Plate System, Atlantis Translational Plate, Atlantis Vision Anterior Cervical, Atlas Cable 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 224.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 23, 2024 | K243007 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 27, 2024 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 16, 2023 | K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 23, 2023 | K223494 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 25, 2022 | K221244 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| December 13, 2021 | K212428 | Centerpiece Plate Fixation System | NQW | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| July 21, 2021 | K211958 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | 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 10, 2020 | K201407 | CD Horizon Spinal System | NKB | 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 |
| January 10, 2020 | K193011 | CD Horizon Fenestrated Screw Set | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 3, 2019 | K191066 | CD Horizon Astute Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 12, 2019 | K191148 | Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set | PML | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 12, 2019 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | 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 26, 2017 | K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | MAX | 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 |
| February 10, 2016 | K153589 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | 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 |
| November 12, 2015 | K152623 | ATLANTIS Anterior Cervical Plate System | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 27, 2015 | K152457 | CD HORIZON Spinal System | NKB | 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 |
| January 21, 2015 | K141599 | DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM | OVE | 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 |
| October 1, 2014 | K142450 | DIVERGENCE Anterior Cervical Fusion System | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 6, 2014 | K141494 | 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 |
| March 13, 2014 | K133205 | CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, 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 |
| June 4, 2013 | K130640 | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | 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 |
| November 16, 2012 | K123246 | CD HORIZON SPIRE Z SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 3, 2012 | K122862 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 28, 2012 | K122433 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| July 5, 2012 | K121680 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| June 29, 2012 | K121191 | VERTEX RCCONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| May 29, 2012 | K110472 | SI-FIX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 9, 2012 | K120368 | CAPSTONE CONTROL SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 17, 2012 | K113252 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 20, 2011 | K113528 | CLYDESDALE(R) SPINAL SYSTEM | MAX | Substantially Equivalent | 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 |
| November 9, 2011 | K110562 | TELAMON PEEK SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| October 21, 2011 | K112473 | CD HORIZON SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| October 12, 2011 | K111264 | CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM | ODP | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| October 4, 2011 | K110063 | SOVEREIGN SPINAL SYSTEM | OVD | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 27, 2011 | K112555 | CD HORIZON(R) SPINAL SYSTEM | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 30, 2011 | K111942 | TSRH SPINAL SYSTEMS | NKB | Unknown | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 18, 2011 | K103731 | CAPSTONE R SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | 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 30, 2010 | K094042 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | OVE | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| June 25, 2010 | K100214 | CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE | ODP | 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 |
| June 2, 2010 | K100175 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 30, 2010 | K091797 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| April 26, 2010 | K094025 | CRESCENT SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | 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 29, 2009 | K090353 | PERIMETER INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | Medtronic Sofamor Danek | 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 |
| February 9, 2009 | K082918 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | MQV | 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 |
| December 29, 2008 | K083026 | CLYDESDALE SPINAL SYSTEM | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| November 21, 2008 | K081080 | TSRH SPINAL SYSTEM | NKB | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 24, 2014 | P090029 | PRESTIGE LP CERVICAL DISC | MJO | 20 | August 9, 2024 | accessdata.fda.gov |
| July 2, 2002 | P000058 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | NEK | 90 | August 26, 2026 | accessdata.fda.gov |
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Updated April 21, 2026. 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.