TLX

GUDID 00887517671639

TLX Implant, 16x13x40mm 12°

Nuvasive, Inc.

Metallic spinal fusion cage, non-sterile
Primary Device ID00887517671639
NIH Device Record Keyc9ab7ccf-eb76-4772-aa9a-71243d33aec5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLX
Version Model Number1742700
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
GS100887517671639 [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

[00887517671639]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-11

On-Brand Devices [TLX]

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00887517987013TLX20 Inserter, Low Profile
00887517987006TLX20 Strike Plate, Low Profile
00887517826169TLX Inserter, w/ Graft Delivery 20°
00887517729415TLX Inserter, Quick Connect
00887517991461TLX 20° LP Inserter Instruments
00887517730633TLX Implant, 9x13x40mm 12°
00887517730626TLX Implant, 9x13x36mm 15°
00887517730619TLX Implant, 9x13x31mm 15°
00887517730602TLX Implant, 9x13x27mm 15°
00887517730596TLX Implant, 9x13x26mm 15°
00887517730589TLX Implant, 9x11x40mm 12°
00887517730558TLX Implant, 9x11x27mm 15°
00887517730480TLX Implant, 8x13x40mm 10°
00887517730473TLX Implant, 8x13x36mm 12°
00887517730466TLX Implant, 8x13x31mm 15°
00887517730459TLX Implant, 8x13x27mm 15°
00887517730442TLX Implant, 8x13x26mm 15°
00887517730435TLX Implant, 8x11x40mm 10°
00887517730404TLX Implant, 8x11x27mm 15°
00887517730381TLX Implant, 7x13x40mm 10°
00887517730374TLX Implant, 7x13x36mm 12°
00887517730367TLX Implant, 7x13x31mm 15°
00887517730350TLX Implant, 7x13x27mm 15°
00887517730343TLX Implant, 7x13x26mm 15°
00887517730336TLX Implant, 7x11x40mm 9°
00887517958587TLX20, 16x11x36mm 15°
00887517958570TLX20, 15x11x36mm 15°
00887517958556TLX20, 13x11x36mm 15°
00887517958518TLX20, 9x11x41mm 13°
00887517958488TLX20, 16x11x41mm 13°
00887517958471TLX20, 15x11x41mm 13°
00887517958464TLX20, 14x11x41mm 13°
00887517958457TLX20, 13x11x41mm 13°
00887517958440TLX20, 12x11x41mm 13°
00887517958433TLX20, 11x11x41mm 13°
00887517958426TLX20, 10x11x41mm 13°
00887517958402TLX20, 9x11x27mm 20°
00887517958372TLX20, 8x11x27mm 20°
00887517958341TLX20, 7x11x27mm 20°
00887517958327TLX20, 16x11x31mm 20°
00887517958310TLX20, 16x11x27mm 20°
00887517958303TLX20, 16x11x26mm 20°
00887517958297TLX20, 15x11x31mm 20°
00887517958280TLX20, 15x11x27mm 20°
00887517958273TLX20, 15x11x26mm 20°
00887517958259TLX20, 14x11x27mm 20°
00887517958235TLX20, 13x11x31mm 20°
00887517958228TLX20, 13x11x27mm 20°
00887517958211TLX20, 13x11x26mm 20°
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