FacetFuse®

GUDID 00190361020752

FacetFuse Screw, Small Washer Assy, 4.5 x 45mm

SPINEFRONTIER, INC.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00190361020752
NIH Device Record Keyc24d310a-78d2-4a2a-a306-09512e486573
Commercial Distribution StatusIn Commercial Distribution
Brand NameFacetFuse®
Version Model NumberIM0061-05
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

Outer Diameter4.5 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100190361020752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190361020752]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-04-15

On-Brand Devices [FacetFuse®]

00190361020950FacetFuse Screw, Small Washer Assy, 6.0 x 50mm
00190361020943FacetFuse Screw, Small Washer Assy, 6.0 x 45mm
00190361020936FacetFuse Screw, Small Washer Assy, 6.0 x 40mm
00190361020929FacetFuse Screw, Small Washer Assy, 6.0 x 35mm
00190361020912FacetFuse Screw, Small Washer Assy, 6.0 x 30mm
00190361020905FacetFuse Screw, Small Washer Assy, 6.0 x 25mm
00190361020899SMALL WASHER, FACET SCREW, ALLSIZES
00190361020882FacetFuse Screw, Small Washer Assy, 5.5 x 50mm
00190361020875FacetFuse Screw, Small Washer Assy, 5.5 x 45mm
00190361020868FacetFuse Screw, Small Washer Assy, 5.5 x 40mm
00190361020851FacetFuse Screw, Small Washer Assy, 5.5 x 35mm
00190361020844FacetFuse Screw, Small Washer Assy, 5.5 x 30mm
00190361020837FacetFuse Screw, Small Washer Assy, 5.5 x 25mm
00190361020820FacetFuse Screw, Small Washer Assy, 5.0 x 50mm
00190361020813FacetFuse Screw, Small Washer Assy, 5.0 x 45mm
00190361020806FacetFuse Screw, Small Washer Assy, 5.0 x 40mm
00190361020790FacetFuse Screw, Small Washer Assy, 5.0 x 35mm
00190361020783FacetFuse Screw, Small Washer Assy, 5.0 x 30mm
00190361020776FacetFuse Screw, Small Washer Assy, 5.0 x 25mm
00190361020769FacetFuse Screw, Small Washer Assy, 4.5 x 50mm
00190361020752FacetFuse Screw, Small Washer Assy, 4.5 x 45mm
00190361020745FacetFuse Screw, Small Washer Assy, 4.5 x 40mm
00190361020738FacetFuse Screw, Small Washer Assy, 4.5 x 35mm
00190361020721FacetFuse Screw, Small Washer Assy, 4.5 x 30mm
00190361020714FacetFuse Screw, Small Washer Assy, 4.5 x 25mm
00190361020707FacetFuse Screw Assy, 5.0 x 25mm
00190361020691FacetFuse Screw, 5.0 x 25mm (Washerless)
00190361020684FacetFuse Screw Assy, 4.5 x 25mm
00190361020677FacetFuse Screw, 4.5 x 25mm (Washerless)
00190361020660FacetFuse Screw Assy, 6.0 x 50mm
00190361020653FacetFuse Screw Assy, 6.0 x 45mm
00190361020646FacetFuse Screw Assy, 6.0 x 40mm
00190361020639FacetFuse Screw Assy, 6.0 x 35mm
00190361020622FacetFuse Screw Assy, 6.0 x 30mm
00190361020615FacetFuse Screw Assy, 6.0 x 25mm
00190361020608FacetFuse Screw Assy, 5.5 x 50mm
00190361020592FacetFuse Screw Assy, 5.5 x 45mm
00190361020585FacetFuse Screw Assy, 5.5 x 40mm
00190361020578FacetFuse Screw Assy, 5.5 x 35mm
00190361020561FacetFuse Screw Assy, 5.5 x 30mm
00190361020554FacetFuse Screw Assy, 5.5 x 25mm
00190361020547FacetFuse Screw, 6.0 x 50mm (Washerless)
00190361020530FacetFuse Screw, 6.0 x 45mm (Washerless)
00190361020523FacetFuse Screw, 6.0 x 40mm (Washerless)
00190361020516FacetFuse Screw, 6.0 x 35mm (Washerless)
00190361020509FacetFuse Screw, 6.0 x 30mm (Washerless)
00190361020493FacetFuse Screw, 6.0 x 25mm (Washerless)
00190361020486FacetFuse Screw, 5.5 x 50mm (Washerless)
00190361020479FacetFuse Screw, 5.5 x 45mm (Washerless)
00190361020462FacetFuse Screw, 5.5 x 40mm (Washerless)

Trademark Results [FacetFuse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FACETFUSE
FACETFUSE
77413369 3620532 Live/Registered
SpineFrontier, Inc.
2008-03-05

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