FDA.reportPublic FDA data

NuVaMap

Primary DI
00887517707291
Brand
NuVaMap
Company
Nuvasive, Inc.
Model
8210348
Device description
NuVaMap O.R. C-Arm Image Converter
Published
2024-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETNSTIMULATOR, NERVE
GWFStimulator, electrical, evoked response
HAWNeurological stereotaxic Instrument
IKNElectromyograph, diagnostic
OLOOrthopedic stereotaxic instrument
PDQNeurosurgical nerve locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2
HAWNeurological Stereotaxic InstrumentNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
OLOOrthopedic Stereotaxic InstrumentNeurology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143641000NuVasive NVM5 SystemNu Vasive, Incorporated2015-03-27PDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517707291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517707291008875177072918875177072910887517707291

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rod bending systemAn assembly of mains electricity (AC-powered) computerized devices intended to be used to determine the relative locations of internal spinal fixation system implants (e.g., screws, hooks) for the production of bend instructions to shape a spinal rod during spinal fusion surgery. It primarily consists of an electronic spatial measurement system used with manual tools to determine implant location and to take measurements; computer/software to convert implant locations to a series of bend instructions; and an orthopaedic rod bender to execute bend instructions. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
03662674000549DSG ConnectSPINEGUARDETN2026-10-22
03662674000549DSG ConnectSPINEGUARDPDQ2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00887868557873ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557880ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557897ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557903ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557910ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558078ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558092ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558146ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558160ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558177ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558306ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575105ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575112ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575129ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575136ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575143ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575150ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575167ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575174ROSA® ShoulderOrthosoft IncOLO2024-03-06