Arena-L®

GUDID 00190361000099

Arena-L, Lordotic 10 degrees, 35X26X08

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00190361000099
NIH Device Record Keycb6a3d6a-2b38-4d3e-a857-0b0b53b82599
Commercial Distribution StatusIn Commercial Distribution
Brand NameArena-L®
Version Model Number01-81005-08
Company DUNS002003243
Company NameSPINEFRONTIER, INC.
Device Count1
DM Exempttrue
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(866)914-7717
Emailcustomerservice@spinefrontier.com

Device Dimensions

Width35 Millimeter
Width35 Millimeter
Width35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361000099 [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

[00190361000099]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-04-15

On-Brand Devices [Arena-L®]

0019036103935821X27 TRIAL HEAD, ARENA-L ALLO, 20MM
0019036103934121X27 TRIAL HEAD, ARENA-L ALLO, 18MM
0019036103933421X27 TRIAL HEAD, ARENA-L ALLO, 16MM
0019036103932721X27 TRIAL HEAD, ARENA-L ALLO, 14MM
0019036103931021X27 TRIAL HEAD, ARENA-L ALLO, 12MM
0019036103930321X27 TRIAL HEAD, ARENA-L ALLO, 10MM
0019036103929721X27 TRIAL HEAD, ARENA-L ALLO, 8MM
0019036103928021X27 TRIAL RASP HEAD, ARENA-L ALLO, 20MM
0019036103927321X27 TRIAL RASP HEAD, ARENA-L ALLO, 18MM
0019036103926621X27 TRIAL RASP HEAD, ARENA-L ALLO, 16MM
0019036103925921X27 TRIAL RASP HEAD, ARENA-L ALLO, 14MM
0019036103924221X27 TRIAL RASP HEAD, ARENA-L ALLO, 12MM
0019036103923521X27 TRIAL RASP HEAD, ARENA-L ALLO, 10MM
0019036103922821X27 TRIAL RASP HEAD, ARENA-L ALLO, 8MM
0019036103921121X27 TRIAL HEAD, ARENA-L ALLO, 21MM
0019036103920421X27 TRIAL HEAD, ARENA-L ALLO, 19MM
0019036103919821X27 TRIAL HEAD, ARENA-L ALLO, 17MM
0019036103918121X27 TRIAL HEAD, ARENA-L ALLO, 15MM
0019036103917421X27 TRIAL HEAD, ARENA-L ALLO, 13MM
0019036103916721X27 TRIAL HEAD, ARENA-L ALLO, 11MM
0019036103915021X27 TRIAL HEAD, ARENA-L ALLO, 9MM
0019036103914321X27 TRIAL RASP HEAD, ARENA-L ALLO, 21MM
0019036103913621X27 TRIAL RASP HEAD, ARENA-L ALLO, 19MM
0019036103912921X27 TRIAL RASP HEAD, ARENA-L ALLO, 17MM
0019036103911221X27 TRIAL RASP HEAD, ARENA-L ALLO, 15MM
0019036103910521X27 TRIAL RASP HEAD, ARENA-L ALLO, 13MM
0019036103909921X27 TRIAL RASP HEAD, ARENA-L ALLO, 11MM
0019036103908221X27 TRIAL RASP HEAD, ARENA-L ALLO, 9MM
001903610390757MM 21X27 TRIAL, ARENA-L ALLO
001903610390687MM 21X27 TRIAL RASP, ARENA-L ALLO
00190361039051Rasp Trial Head, 38X28 Lordotic 12°, 17L
00190361039044Rasp Trial Head, 38X28 Lordotic 12°, 15L
00190361039037Rasp Trial Head, 38X28 Lordotic 12°, 13L
00190361039020Rasp Trial Head, 38X28 Lordotic 12°, 11L
00190361039013Rasp Trial Head, 35X26 Lordotic 12°, 17L
00190361039006Rasp Trial Head, 35X26 Lordotic 12°, 15L
00190361038993Rasp Trial Head, 35X26 Lordotic 12°, 13L
00190361038986Rasp Trial Head, 35X26 Lordotic 12°, 11L
00190361038979Rasp Trial Head, 38X28 Lordotic 8°, 17L
00190361038962Rasp Trial Head, 38X28 Lordotic 8°, 15L
00190361038955Rasp Trial Head, 38X28 Lordotic 8°, 13L
00190361038948Rasp Trial Head, 38X28 Lordotic 8°, 11L
00190361038931Rasp Trial Head, 38X28 Lordotic 8°, 9L
00190361038924Flat Trial Head, 38X28 Lordotic 8°, 19L
00190361038917Flat Trial Head, 38X28 Lordotic 8°, 17L
00190361038900Flat Trial Head, 38X28 Lordotic 8°, 15L
00190361038894Flat Trial Head, 38X28 Lordotic 8°, 13L
00190361038887Flat Trial Head, 38X28 Lordotic 8°, 11L
00190361038870Flat Trial Head, 38X28 Lordotic 8°, 9L
00190361038863Rasp Trial Head, 35X26 Lordotic 8° 17L

Trademark Results [Arena-L]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARENA-L
ARENA-L
85648864 4408106 Live/Registered
SpineFrontier, Inc.
2012-06-11

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