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Nuvasive, Inc.

United States·US-MF-000007421

Last updated September 17, 2026

Information

Country
United States
Address
7475, Lusk Blvd, San Diego, United States
LinkedIn
—
Facebook
—
Phone
+1-858-909-1800
PRRC Contact
Daniel S. Paul
EUDAMED SRN
US-MF-000007421
FDA FEI Number
3002980729
DUNS Number
053950783

Catalogue (44291)

Page 22 of 500
DeviceModel / ReferenceRegistriesClassStatus
MaXcess 1012928
FDA UDI
Class IIActive
Xlp 7533012
FDA UDI
Class IIActive
CoRoent 6714923
FDA UDI
Class IIActive
ReLine 12260170
FDA UDI
Class IIActive
VuePoint 7905432
FDA UDI
Class IIActive
CoRoent 6725435
FDA UDI
Class IIActive
ReLine 13031125
FDA UDI
Class IIActive
X-Core 7220016
FDA UDI
Class IIActive
MaXcess 3401110
FDA UDI
Class IActive
MaXcess 3405060
FDA UDI
Class IActive
ReLine 16175550P
FDA UDI
Class IIActive
ReLine 18160002P
FDA UDI
Class IIActive
ReLine 11107255P
FDA UDI
Class IIActive
CoRoent 5279368P2
FDA UDI
Class IIActive
ReLine 14516012
FDA UDI
Class IIActive
ReLine 10245500
FDA UDI
Class IIActive
ReLine 14511110
FDA UDI
Class IIActive
Monolith 5992740
FDA UDI
Class IIActive
ReLine 11106160
FDA UDI
Class IIActive
Brigade 6987034
FDA UDI
Class IIActive
CoRoent 5101400P2
FDA UDI
Class IIActive
ReLine 14584012
FDA UDI
Class IIActive
CoRoent 5240304P2
FDA UDI
Class IIActive
Gradient 7450617
FDA UDI
Class IIActive
ReLine 3946400
FDA UDI
Class IIActive
ReLine 14546085
FDA UDI
Class IIActive
CoRoent 6300660
FDA UDI
Class IIActive
ReLine 13316060P
FDA UDI
Class IIActive
ReLine 11088555
FDA UDI
Class IIActive
NuVasive 1006723
FDA UDI
Class IActive
ReLine 20345020
FDA UDI
Class IIActive
ReLine 13044530A
FDA UDI
Class IIActive
Base 6958112
FDA UDI
Class IActive
CoRoent 5394308
FDA UDI
Class IIActive
ReLine D10000684
FDA UDI
Class IActive
ReLine 14250135
FDA UDI
Class IIActive
Helix 7737110
FDA UDI
Class IIActive
MaXcess 3231120
FDA UDI
Class IActive
CoRoent 1689150
FDA UDI
Class IIActive
Pcm 7670110
FDA UDI
Class IIIActive
Pgi 1008949
FDA UDI
Class IActive
ReLine 3700042
FDA UDI
Class IIActive
CoRoent 6081025P
FDA UDI
Class IIActive
Pcm 7691280
FDA UDI
Class IIIActive
ReLine 13314540P
FDA UDI
Class IIActive
ReLine 16088550
FDA UDI
Class IIActive
ReLine 10150342
FDA UDI
Class IIActive
CoRoent 5221304
FDA UDI
Class IIActive
CoRoent 6852014
FDA UDI
Class IIActive
ReLine 12260380
FDA UDI
Class IIActive

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (36)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 10, 2022Z-0738-2023—open, classified

Potential that insert will be unable to disengage from the vertebral body replacement device/implant

Jul 19, 2022Z-1052-2023—open, classified

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.

Jun 20, 2022Z-1453-2022—open, classified

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.

Jun 10, 2020Z-2684-2020—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.

Feb 13, 2020Z-1898-2020—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.

Jan 5, 2009Z-0369-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0361-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0351-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0370-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0375-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0348-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0354-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0377-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0355-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0374-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0378-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0352-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0372-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0363-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0350-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0364-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0367-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0359-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0366-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0373-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0362-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0349-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0360-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0353-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0365-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0376-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0371-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0357-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0358-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0368-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0356-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.