Data / Medical devices / United States / Nuvasive, Inc.
Nuvasive, Inc.: FDA-registered device maker in Guaynabo, PR, United States, 94 510(k) clearances and 1 PMA approval
Nuvasive, Inc. is registered with the FDA (registration 3009144915) in Guaynabo, PR, United States. It lists 42 device types. The FDA files 94 510(k) clearances and 1 PMA approval under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009144915
- Address
- City View Plaza 1 Suites 116 & 117 #48 Rd 165 Km 1.2, Guaynabo, PR, United States, 00968
- Owner or operator
- NUVASIVE, INC. (9036345)
- Roles
- Manufacturer
- First device listed
- October 17, 2006
- Registered through
- 2026
- Brand names listed
- Armada Spinal Fixation system, Bendini Cloud Application, CoRoent Small Contoured Interbody System, CoRoent Small Interbody System, CoRoent Small Interlock II System, CoRoent Small Interlock System, CoRoent Small Ti-C System, Coalesce Lumbar Interbody Fusion 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 2, 2024 | K233706 | Bendini Cloud Application | OLO | Substantially Equivalent | Nuvasive | accessdata.fda.gov |
| March 20, 2024 | K240507 | NuVasive AttraX Scaffold | MQV | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| February 6, 2024 | K233593 | MAGEC Spinal Bracing and Distraction System | PGN | Substantially Equivalent | Nuvasive Specialized Orthopedics, Incorporated | accessdata.fda.gov |
| August 29, 2023 | K230765 | Precice Ankle Salvage System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| July 11, 2023 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | ODP | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| June 16, 2023 | K230894 | NuVasive Modulus ALIF System | OVD | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 5, 2023 | K230989 | Rod Registration Frame | OLO | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| March 15, 2023 | K220234 | Precice Intramedullary Limb Lengthening System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| January 12, 2023 | K223731 | NuVasive Modulus-C Interbody System | ODP | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| January 11, 2023 | K223181 | NuVasive Reline System | NKB | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 21, 2022 | K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | OVD | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 9, 2022 | K221388 | NuVasive Reline Cervical System | NKG | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| June 21, 2022 | K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| February 23, 2022 | K213654 | NuVasive Reline Cervical System | NKG | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| December 23, 2021 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 3, 2021 | K212446 | NuVasive Anterior Cervical Plate Systems | KWQ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| August 20, 2021 | K211757 | Simplify Disc | QLQ | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| July 29, 2021 | K210574 | NuVasive Pulse System | OLO | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 24, 2021 | K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 12, 2021 | K210439 | NuVasive MOD-EX XLIF Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| March 1, 2021 | K210271 | NuVasive Modulus ALIF System | OVD | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| January 12, 2021 | K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| December 22, 2020 | K202348 | External Remote Controller ERC 4P | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| December 3, 2020 | K203253 | NuVasive ACP System | KWQ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| December 2, 2020 | K200719 | NuVasive Navigation.S Instruments | OLO | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 29, 2020 | K201692 | NuVasive Modulus XLIF Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 6, 2020 | K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 25, 2020 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 16, 2020 | K200430 | Precice® Ankle Salvage System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| August 10, 2020 | K201567 | Precice® Bone Transport System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| July 30, 2020 | K201543 | MAGEC® System | PGN | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| May 21, 2020 | K200956 | NuVasive Thoracolumbar Plates | KWQ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 20, 2020 | K201078 | NuVasive® ACP System | KWQ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 8, 2020 | K193617 | Precice® Screws | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| May 8, 2020 | K193016 | PRECICE Bone Transport System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| March 30, 2020 | K193541 | NuVasive Cohere Thoracolumbar Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| March 25, 2020 | K193593 | NuVasive 3DP Interfixated ALIF System | OVD | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| February 26, 2020 | K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | MQP | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 13, 2019 | K192582 | NuVasive CoRoent Small Interlock System | OVE | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 7, 2019 | K192181 | PRECICE Plating System | KTT | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| November 3, 2019 | K191974 | NuVasive AttraX Putty | MQV | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 19, 2019 | K190636 | NuVasive® Reline® 4.5-5.0 System | NKB | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 18, 2019 | K192760 | NuVasive Modulus XLIF Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 26, 2019 | K192435 | NuVasive NuvaLine | LLZ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 26, 2019 | K191336 | PRECICE System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| September 3, 2019 | K191500 | NuVasive® ACP System | KWQ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| August 14, 2019 | K191553 | NuVaisve® Reline® Cervical System | NKG | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| July 3, 2019 | K191169 | NuVasive® Camber Laminoplasty System | NQW | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| March 21, 2019 | K190418 | NuVasive® VersaTie® System | OWI | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| February 13, 2019 | K182974 | NuVasive Reline System | NKB | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| February 5, 2019 | K182170 | PRECICE® BONE TRANSPORT System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| November 28, 2018 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | PML | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 20, 2018 | K180550 | NuVasive Monolith Cervical Corpectomy System | PLR | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 5, 2018 | K181860 | NuVasive Cohere Thoracolumbar Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| August 24, 2018 | K181386 | NuVasive Brigade Lateral System | OVD | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| June 29, 2018 | K180038 | NuVasive Pulse System | OLO | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 4, 2018 | K173892 | NuVasive® XLX Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| April 3, 2018 | K180503 | PRECICE STRYDE System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| March 15, 2018 | K180198 | NuVasive® VuePoint® II OCT System | NKG | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| February 8, 2018 | K173025 | NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| December 21, 2017 | K172623 | NuVasive Navigation Instruments | OLO | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| December 14, 2017 | K172676 | NuVasive® Modulus-C Interbody System | ODP | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| December 7, 2017 | K173117 | NuVasive® VersaTie System | OWI | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| December 6, 2017 | K173153 | Vertera Spine Coalesce Thoracolumbar Interbody Fusion System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 24, 2017 | K172497 | NuVasive AttraX Scaffold | MQV | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 21, 2017 | K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | ODP | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 16, 2017 | K173314 | LessRay System | OWB | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| November 6, 2017 | K172979 | NuVasive® Growth Rod Conversion Set | PGM | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 26, 2017 | K172341 | NuVasive® Modulus TLIF Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| October 11, 2017 | K172123 | NuVasive® Modulus XLIF Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 28, 2017 | K171894 | NuVasive® Precept Spinal System | NKB | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 28, 2017 | K171633 | NuVasive TLX Interbody System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| September 25, 2017 | K172628 | PRECICE System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| August 31, 2017 | K171791 | MAGEC® System | PGN | Substantially Equivalent | Nuvasive Specialized Orthopedics, Incorporated | accessdata.fda.gov |
| August 24, 2017 | K172061 | PRECICE UNYTE System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| August 18, 2017 | K170800 | NuVasive LessRay with Enhanced Tracking | OWB | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| June 26, 2017 | K170962 | NuVasive® CoRoent® Thoracolumbar System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| June 19, 2017 | K163506 | Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Vertera, Inc. | accessdata.fda.gov |
| June 9, 2017 | K170169 | PRECICE Intramedullary Limb Lengthening System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| June 8, 2017 | K170961 | NuVasive CoRoent Small Interlock II System | OVE | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 1, 2017 | K163707 | NuVasive CoRoent Ti-C System | MAX | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| May 1, 2017 | K162647 | NuVasive NuvaLine Mobile App | LLZ | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| April 26, 2017 | K170592 | NuVasive BASE Interfixated Titanium System | OVD | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| April 6, 2017 | K162927 | PRECICE UNYTE CoCr System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| March 30, 2017 | K170271 | NuVasive(r) Monolith Corpectomy System | MQP | Substantially Equivalent | Nu Vasive, Incorporated | accessdata.fda.gov |
| March 7, 2017 | K170346 | PRECICE Intramedullary Limb Lengthening System | HSB | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| September 2, 2016 | K161751 | MAGEC® Spinal Bracing and Distraction System | PGN | Substantially Equivalent | Nuvasive Specialized Orthopedics, Inc. | accessdata.fda.gov |
| September 23, 2015 | K143685 | Hedgehog Cervical Interbody Fusion Device | ODP | Substantially Equivalent | Vertera, Inc. | accessdata.fda.gov |
| January 10, 2011 | K103036 | ALLOFUSE PLUS | MQV | Substantially Equivalent | Allosource, Inc. | accessdata.fda.gov |
| July 18, 2006 | K061778 | NUVASIVE SPHERX II SYSTEM | MNH | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| September 15, 2005 | K051718 | NUVASIVE NEUROVISION JJB SYSTEM | ETN | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| May 27, 2005 | K050789 | FORMAGRAFT COLLAGEN BONE GRAFT MATRIX | MQV | Substantially Equivalent | R and D Medical, LLC | accessdata.fda.gov |
| October 26, 2004 | K042034 | NUVASIVE MAXCESS LIGHT GUIDE | FST | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| March 12, 2002 | K020411 | NUVASIVE TRIAD FACET SCREW SYSTEM | MRW | Substantially Equivalent | Nuvasive, Inc. | 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 |
|---|---|---|---|---|---|---|
| September 18, 2020 | P200022 | Simplify® Cervical Artificial Disc | MJO | 17 | June 5, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Spinal Vertebral Body Replacement Device
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Rod, Fixation, Intramedullary And Accessories
Updated June 5, 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.