XLX

GUDID 00887517940131

XLX ACR Interbody, 8x23x50mm

Nuvasive, Inc.

Metallic spinal fusion cage, non-sterile
Primary Device ID00887517940131
NIH Device Record Key3ff58b4a-a232-48ac-9c4c-1fa041e300eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameXLX
Version Model Number1675078
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517940131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PHMIntervertebral fusion device with bone graft, thoracic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887517940131]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-02
Device Publish Date2018-07-02

On-Brand Devices [XLX]

00887517944900XLX ACR Set Screw, Plate
00887517943897XLX ACR Plug, Graft Containment
00887517945204XLX ACR Inserter, Low Profile
00887517944986XLX ACR Inserter, Standard
00887517944962XLX ACR Expansion Driver, Std Inserter
00887517944955XLX ACR Drive Shaft, Standard Inserter
00887517944948XLX ACR Inserter Adapter, Unplated
00887517944931XLX ACR Shaft, Main Unplted Std Inserter
00887517944924XLX ACR Shaft, Main Plated Std Inserter
00887517944856XLX ACR Shaft, Unplated LP Inserter
00887517944849XLX ACR Shaft, Plated LP Inserter
00887517968616XLX ACR T-Handle, Torque Limiting
00887517960313XLX ACR Plate, 18.0mm
00887517960306XLX ACR Plate, 17.0mm
00887517960290XLX ACR Plate, 16.0mm
00887517960283XLX ACR Plate, 15.0mm
00887517960276XLX ACR Plate, 14.0mm
00887517960269XLX ACR Plate, 12.0mm
00887517960252XLX ACR Plate, 12.0mm
00887517960245XLX ACR Plate, 11.0mm
00887517954961XLX ACR Trial, 12mm 30°
00887517954954XLX ACR Trial, 10mm 30°
00887517954947XLX ACR Trial, 8mm 30°
00887517954930XLX ACR Trial, 6mm 30°
00887517954923XLX ACR Trial, 4mm 30°
00887517954916XLX ACR Trial, 12mm 20°
00887517954909XLX ACR Trial, 10mm 20°
00887517954503Alpha XLX ACR Instrument Tray 2
00887517953698Alpha XLX ACR Instrument Tray 1
00887517953681Alpha XLX ACR Implant Tray
00887517947994XLX ACR Trial, 8mm 20°
00887517947987XLX ACR Trial, 6mm 20°
00887517947970XLX ACR Trial, 4mm 20°
00887517947451XLX ACR Loading Block
00887517947437XLX ACR Counter Torque
00887517945228XLX ACR Distractor, Parallel
00887517945211XLX ACR Awl
00887517945174XLX ACR Blade Clip, Posterior
00887517945167XLX ACR Driver, Screw Final
00887517945136XLX ACR Cutter, Ant Longitud Ligament W
00887517945129XLX ACR Driver, Expansion Stand Alone
00887517945112XLX ACR Driver, Long S.S./Graft Plug
00887517945105XLX ACR Driver, Short S.S./Graft Plug
00887517945099XLX ACR Trial, 12mm 10°
00887517945082XLX ACR Trial, 10mm 10°
00887517945075XLX ACR Trial, 8mm 10°
00887517945068XLX ACR Trial, 6mm 10°
00887517945051XLX ACR Trial, 4mm 10°
00887517945044XLX ACR Cutter, Ant LongitudLigament Nrw
00887517945037XLX ACR Funnel, Graft
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