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Nuvasive, Inc.

Active in EUDAMED

Registered as NuVasive, LLC in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000007421 FEI 3002980729

Nuvasive, Inc. is a medical device manufacturer based in the United States, with 98 devices listed in 4 registries (FDA Class II, Unclassified and Class III; EU Class I) and 36 FDA recalls as of 13 Nov 2026.

Devices
98
Registrations
EUDAMEDFDA
FDA recalls
363 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 91
  • EUDAMED 5
  • FDA GUDID 4
  • FDA PMA 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 87
  • EU Class I 5
  • FDA Unclassified 4
  • FDA Class III 2
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000007421
  • FDA FEI 3002980729
  • DUNS 053950783

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
AJW Technology Consulting GmbHDE

What Nuvasive, Inc. makes

Nuvasive, Inc. manufactures spinal fixation devices, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, and internal fixation rods for surgical stabilization. Their portfolio also includes spinal implant trials, non-bioabsorbable spinal plates, reusable surgical retraction systems, and reusable internal fixation procedure kits. Devices like ReLine, CoRoent, BASE, Precept, XLIF, and TLIF are designed for spinal procedures such as fusion and stabilization.

The company’s products are regulated under FDA classifications, including Class I, Class II, and Class III devices, and are listed in the FDA’s Unique Device Identifier (UDI) database. Nuvasive, Inc. is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue98

Newest first, rows 1-50 of 98

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Rows 1-50 of 98

Showing 1-50 of 98

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000007421
FDA FEI number
3002980729
DUNS number
053950783
EUDAMED status
Active
EUDAMED registered name
NuVasive, LLC
Registered address
7475, Lusk Blvd, 92121, San Diego, United States
Phone
+1-858-909-1800
PRRC contact
Daniel S. Paul(public in EUDAMED)

FDA recalls36

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 36 recalls initiated by Nuvasive, Inc., the earliest on 2009-01-05 and the most recent on 2022-11-10. By recorded status: 3 ongoing and 33 terminated. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 2
  • 2021 0
  • 2022 3
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

31 initiated before 2017

Showing the 10 most recent of 36 recalls.

  • 2022

    • 10 Nov 2022 Z-0738-2023 Class II Ongoing Potential that insert will be unable to disengage from the vertebral body replacement device/implant Distribution: Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of NC, CA, FL, KY, IL, TX, CO, OH, AK, GA, UT, MA, WA, HI, AL, NY, WI, AR, ID, VA, PA, SC, MD, PA, AZ, RI, IN, ME, NJ, MI, TN, MN, OR, OK, WY, and Puerto Rico. The countries of Australia, Belgium, Brazil, Colombia, Germany, Italy, Spain, and United Kingdom.
      Submission number: K090176
    • 19 Jul 2022 Z-1052-2023 Class III Ongoing Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures. Distribution: U.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX. Submission number: K210574
    • 20 Jun 2022 Z-1453-2022 Class II Ongoing Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit. Distribution: US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK Submission number: P200022

  • 2020

    • 10 Jun 2020 Z-2684-2020 Class II Terminated The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5. Distribution: US Nationwide distribution including in the states of AR, CA, IA, IL, WI. OUS: None Submission number: K143641
    • 13 Feb 2020 Z-1898-2020 Class II Terminated Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA,…
      Full distribution text Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The Countries of Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Ireland, Italy, Jordan, Kuwait, Luxembourg, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Saudi Arabia, Slovenia/Serbia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
      Submission number: K171791

  • 2009

    • 5 Jan 2009 Z-0348-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0349-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0350-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0351-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0352-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
Show the 25 most recent of 36 recalls

  • 2009

    • 5 Jan 2009 Z-0353-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0354-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0355-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0356-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0357-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0358-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0359-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0360-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0361-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0362-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0363-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0364-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0365-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0366-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332
    • 5 Jan 2009 Z-0367-2013 Class II Terminated The tulip portion of the screw assembly can disengage from the shank after implantation. Distribution: Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. Submission number: K082332

Frequently asked questions

How many devices does Nuvasive, Inc. have in the registry?

The registry currently lists 98 devices for Nuvasive, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Nuvasive, Inc.'s devices?

Among its 50 most recently registered devices, Nuvasive, Inc. has devices listed in EUDAMED (1 device), FDA 510(k) (49 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Nuvasive, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Nuvasive, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Nuvasive, Inc.?

FDA recall records list 36 recalls initiated by Nuvasive, Inc., the most recent initiated on 10 Nov 2022. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Nuvasive, Inc. in the registry?

The most recently registered devices listed for Nuvasive, Inc. include PULSE, NUVASIVE COROENT SYSTEM, NUVASIVE COROENT TITANIUM SYSTEM and MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.