Arena-C

GUDID 00190361023159

Arena-C HA, 11X17 Straight, 10mm

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00190361023159
NIH Device Record Key6095af03-0546-429b-bbef-fcae183e079b
Commercial Distribution StatusIn Commercial Distribution
Brand NameArena-C
Version Model Number01-72037-10
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

Height10 Millimeter
Height10 Millimeter
Height10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361023159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190361023159]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-12-01

On-Brand Devices [Arena-C]

00190361023173Arena-C HA, 11X17 Straight, 12mm
00190361023166Arena-C HA, 11X17 Straight, 11mm
00190361023159Arena-C HA, 11X17 Straight, 10mm
00190361023142Arena-C HA, 12x15, Straight 12mm
00190361023135Arena-C HA, 12x15, Straight 11mm
00190361023128Arena-C HA, 12x15, Straight 10mm
00190361023111Arena-C HA, 11X17 Straight, 9mm
00190361023104Arena-C HA, 11X17 Straight, 8mm
00190361023098Arena-C HA Straight 7mm 11x17 IBFD
00190361023081Arena-C HA Straight 6mm 11x17 IBFD
00190361023074Arena-C HA Straight 5mm 11x17 IBFD
0019036102306712x15 Arena-C PEEK HA Straight 5mm
0019036102305012x15 Arena-C PEEK HA Straight 6mm
0019036102304312x15 Arena-C PEEK HA Straight 7mm
0019036102303612x15 Arena-C PEEK HA Straight 8mm
0019036102302912x15 Arena-C PEEK HA Straight 9mm

Trademark Results [Arena-C]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ARENA-C
ARENA-C
85836783 4392274 Live/Registered
SpineFrontier, Inc.
2013-01-30

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