APX

GUDID 00887517451583

XLIF® APX, 8x30x50mm 10°

Nuvasive, Inc.

Vertebral body prosthesis, non-sterile
Primary Device ID00887517451583
NIH Device Record Keyde1f9c6f-80e3-4eba-9417-68b74e63e777
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPX
Version Model Number1672311
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 Usefalse
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
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517451583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887517451583]

Moist Heat or Steam Sterilization


[00887517451583]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [APX]

00887517514844Alpha AP Expandable XLIF Instrument Set
00887517514837Alpha AP Expandable XLIF Implant Set
00887517514820Alpha AP Expandable XLIF Graft Delivery
00887517454072XLIF® APX, 12x30x55mm 10°
00887517454065XLIF® APX, 12x26x55mm 10°
00887517454058XLIF® APX, 10x30x55mm 10°
00887517454041XLIF® APX, 10x26x55mm 10°
00887517454034XLIF® APX, 8x30x55mm 10°
00887517454027XLIF® APX, 8x26x55mm 10°
00887517454010XLIF® APX, 12x30x50mm 10°
00887517454003XLIF® APX, 12x26x50mm 10°
00887517453693XLIF® APX, 12x26x50mm 0°
00887517453686XLIF® APX, 10x30x50mm 10°
00887517451903XLIF® APX, 10x26x50mm 10°
00887517451590XLIF® APX, 10x26x50mm 0°
00887517451583XLIF® APX, 8x30x50mm 10°
00887517451576XLIF® APX, 8x26x50mm 10°
00887517451569XLIF® APX, 8x26x50mm 0°
00887517210173XLIF APX Inserter, Expandable
00887517184764XLIF® APX, 12x30x55mm 0°
00887517184757XLIF® APX, 10X30X55mm 0°
00887517184740XLIF® APX, 8X30X55mm 0°
00887517211811XLIF APX Rod, 26x55mm
00887517211019XLIF APX Rod, 30x55mm
00887517211002XLIF APX Rod, 26x50mm
00887517199805XLIF APX Shim, Long
00887517211422XLIF APX Template, 26x50mm
00887517210593XLIF APX Template, 30x55mm
00887517210586XLIF APX Template, 30x50mm
00887517210579XLIF APX Template, 30x50mm
00887517453617XLIF APX Tray, PA Base Level

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