A-CIFT® SoloFuse®

GUDID 00190361037217

TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 10MM

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00190361037217
NIH Device Record Key6c912226-c0a6-41a6-8ea3-a6d757afd3dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameA-CIFT® SoloFuse®
Version Model Number11-32001-1710
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 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(866)914-7717
Emailcustomerservice@spinefrontier.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361037217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190361037217]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-10-05

On-Brand Devices [A-CIFT® SoloFuse®]

0019036103740813X17X12 AO TRIAL, LORDOTIC
0019036103739213X17X11 AO TRIAL, LORDOTIC
0019036103738513X17X10 AO TRIAL, LORDOTIC
0019036103737813X17X9 AO TRIAL, LORDOTIC
0019036103736113X17X8 AO TRIAL, LORDOTIC
0019036103735413X17X7 AO TRIAL, LORDOTIC
0019036103734713X17X6 AO TRIAL, LORDOTIC
0019036103733013X17X5 AO TRIAL, LORDOTIC
00190361037323FREEHAND SLIM PEEK INSERTER
00190361037316TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 12MM
00190361037309TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 11MM
00190361037293TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 10MM
00190361037286TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 9MM
00190361037279TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 8MM
00190361037262TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 7MM
00190361037255TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 6MM
00190361037248TRIAL RASP, ASSEMBLY, LORDOTIC - 14 X 17 X 5MM
00190361037231TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 12MM
00190361037224TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 11MM
00190361037217TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 10MM
00190361037200TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 9MM
00190361037194TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 8MM
00190361037187TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 7MM
00190361037170TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 6MM
00190361037163TRIAL ASSEMBLY, LORDOTIC - 14 X 17 X 5MM
00190361037156SLIM GUIDE, SLIM PEEK INSERTER - 12MM
00190361037149SLIM GUIDE, SLIM PEEK INSERTER - 11MM
00190361037132SLIM GUIDE, SLIM PEEK INSERTER - 10MM
00190361037125SLIM GUIDE, SLIM PEEK INSERTER - 9MM
00190361037118SLIM GUIDE, SLIM PEEK INSERTER - 8MM
00190361037101SLIM GUIDE, SLIM PEEK INSERTER - 7MM
00190361037095SLIM GUIDE, SLIM PEEK INSERTER - 6MM
00190361037088SLIM GUIDE, SLIM PEEK INSERTER - 5MM
00190361037071FREEHAND TIP, SLIM INSERTER
00190361037064SLIM PEEK INSERTER ASSY
00190361037057RETRACTABLE AWL
00190361023722A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 12mm Height HA PEEK
00190361023715A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 11mm Height HA PEEK
00190361023708A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 10mm Height HA PEEK
00190361023692A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 9mm Height HA PEEK
00190361023685A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 8mm Height HA PEEK
00190361023678A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 7mm Height HA PEEK
00190361023661A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 6mm Height HA PEEK
00190361023654A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 5mm Height HA PEEK
00190361021636A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 12mm
00190361021629A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 11mm
00190361021612A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 10mm
00190361021605A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 9mm
00190361021599A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 8mm
00190361021582A-CIFT SoloFuse PEEK IBDF, Dual C Lock Lordotic 13LX17W, 7mm

Trademark Results [A-CIFT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
A-CIFT
A-CIFT
85836823 4860094 Live/Registered
SpineFrontier, Inc.
2013-01-30

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