FDA.reportPublic FDA data

NuVasive

Primary DI
00887517090324
Brand
NuVasive
Company
Nuvasive, Inc.
Model
1538324
Device description
Universal Set Screw Tip, Envoy
Published
2019-12-16
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517090324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517090324008875170903248875170903240887517090324

GMDN Terms#

Term, Definition table
TermDefinition
External spinal fixation systemAn assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517656582ReLine13125560131255602026-04-15
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377006424CoRoent6791713P26791713P22026-05-08
00195377006431CoRoent6791712P26791712P22026-05-08
00887517051905CoRoent6791715P26791715P22026-05-08
00887517051912CoRoent6791716P26791716P22026-05-08
00887517051929CoRoent6791812P26791812P22026-05-08
00887517051936CoRoent6791813P26791813P22026-05-08
00887517051943CoRoent6791814P26791814P22026-05-08
00887517051950CoRoent6791815P26791815P22026-05-08
00887517051967CoRoent6791816P26791816P22026-05-08
00887517180513MaXcess32000282022-07-20
00887517063434MaXcess10109872019-11-21
00887517074973MaXcess10254612019-11-21
00887517183323MaXcess32001202019-11-21
00887517183378MaXcess32002202019-11-21
00887517206084MaXcess34000332019-11-21
00887517206572MaXcess34000442019-11-21
00887517497222MaXcess32410022019-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008500783961982.2 TITAN Nail Instrument KitEca Medical InstrumentsLXH2026-06-23
008500783962043.0 TITAN Nail Instrument KitEca Medical InstrumentsLXH2026-06-23
008500783962284.0 TITAN Nail Instrument KitEca Medical InstrumentsLXH2026-06-23
008500783962352.2-4.0 TITAN Nail SizerEca Medical InstrumentsLXH2026-06-23
008500783962422.2 TITAN Nail Accessory KitEca Medical InstrumentsLXH2026-06-23
008500783962593.0 TITAN Nail Accessory KitEca Medical InstrumentsLXH2026-06-23
008500783962734.0 TITAN Nail Accessory KitEca Medical InstrumentsLXH2026-06-23
008401944957693P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944957763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944957833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944957903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
008401944958063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.LXH2026-06-10
00857915007774Measuring DeviceA.M. SURGICAL, INC.LXH2026-06-10
00889795154552Spider Monkey Bone Transport SystemParagon 28, Inc.LXH2026-06-10
00889795154569Spider Monkey Bone Transport SystemParagon 28, Inc.LXH2026-06-10
00889795154576Spider Monkey Bone Transport SystemParagon 28, Inc.LXH2026-06-10
00841732164284GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-15
00841732164123GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164147GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164154GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164161GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164178GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164192GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
00841732164239GENERIC Surgical InstrumentsCTL Medical CorporationLXH2023-09-14
03701037311615ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSLXH2023-01-24
03701037311622ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSLXH2023-01-24
03701037311639ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSLXH2023-01-24
03701037318102ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSLXH2023-01-24
03701037318119ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSLXH2023-01-24
03701037311585ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSLXH2023-01-17