PedFuse

GUDID 00190361034582

Straight Pedicle Rod CoCr Ø5.5 X 100MM

SPINEFRONTIER, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190361034582
NIH Device Record Keycb6bb35e-dfe9-4a75-a80b-7857271b7552
Commercial Distribution StatusIn Commercial Distribution
Brand NamePedFuse
Version Model Number01-80164-55100
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

Length100 Millimeter
Length100 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361034582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190361034582]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [PedFuse]

00190361035374Sliding Washer
00190361035367CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 50MM
00190361035350CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 45MM
00190361035343CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 40MM
00190361035336CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø5.0MM X 35MM
00190361035329CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 50MM
00190361035312CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 45MM
00190361035305CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 40MM
00190361035299CANNULATED, RESPOND-XL SCREW ASSY, ø5.0MM X 35MM
00190361035282CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 80MM
00190361035275CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 75MM
00190361035268CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 70MM
00190361035251CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 65MM
00190361035244CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 60MM
00190361035237CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 55MM
00190361035220CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 50MM
00190361035213CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 45MM
00190361035206CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 40MM
00190361035190CANNULATED,RESPOND-XL SCREW ASSY, RBM, ø7.0MM X 35MM
00190361035183CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 55MM
00190361035176CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 50MM
00190361035169CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 45MM
00190361035152CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 40MM
00190361035145CANNULATED, RESPOND-XL SCREW ASSY, RBM, ø6.0MM X 35MM
00190361035138CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 80MM
00190361035121CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 75MM
00190361035114CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 70MM
00190361035107CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 65MM
00190361035091CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 60MM
00190361035084CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 55MM
00190361035077CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 50MM
00190361035060CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 45MM
00190361035053CANNULATED, RESPOND-XL SCREW ASSY, ø7.0MM X 40MM
00190361035046CANNULATED,RESPOND-XL SCREW ASSY, ø7.0MM X 35MM
00190361035039CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 55MM
00190361035022CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 50MM
00190361035015CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 45MM
00190361035008CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 40MM
00190361034995CANNULATED, RESPOND-XL SCREW ASSY, ø6.0MM X 35MM
00190361034988Remind Quad-H Solid 6.5x55
00190361034971Remind Quad-H Solid 6.5x50
00190361034964Remind Quad-H Solid 6.5x45
00190361034957Remind Quad-H Solid 6.5x40
00190361034940Remind Quad-H Solid 6.5x35
00190361034933Remind Quad-H Solid RBM 6.5x30
00190361034926Remind Quad-H Solid 6.5x30
00190361034919Remind Quad Solid 6.5x50
00190361034902Remind Quad Solid 6.5x45
00190361034896Remind Quad Solid 6.5x40
00190361034889Remind Quad Solid 6.5x35

Trademark Results [PedFuse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDFUSE
PEDFUSE
77899454 3882390 Live/Registered
SpineFrontier, Inc.
2009-12-22

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