ELLIPSE

GUDID 00849044035438

3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 8mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00849044035438
NIH Device Record Key5dd21964-de8d-4fb6-a176-3aae8cfd83b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameELLIPSE
Version Model Number582.308
Company DUNS139105691
Company NameGLOBUS MEDICAL, INC.
Device Count1
DM Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)930-1800
Emailinfo@globusmedical.com

Device Dimensions

Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849044035438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849044035438]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-11-07

On-Brand Devices [ELLIPSE]

00849044036404CoCr Tapered Rod, 3.5mm to 5.5mm, 500mm
00849044036398CoCr Tapered Rod, 3.5mm to 6.5mm, 350mm
00849044036381CoCr Tapered Rod, 3.5mm to 6.35mm, 350mm
00849044036374CoCr Tapered Rod, 3.5mm to 6.0mm, 350mm
00849044036367CoCr Tapered Rod, 3.5mm to 5.5mm, 350mm
00849044036350CoCr Tapered Rod, 3.5mm to 5.0mm, 350mm
00849044036343CoCr Tapered Rod, 3.5mm to 4.5mm, 350mm
00849044036336CoCr Tapered Rod, 3.5mm to 4.0mm, 350mm
00849044036329CoCr Tapered Rod, 3.5mm to 3.7mm, 350mm
008490440363123.5mm CoCr Occipital Rod 240mm, 130°
008490440363053.5mm CoCr Occipital Rod 240mm, 115°
008490440362993.5mm CoCr Occipital Rod 240mm, 100°
008490440362823.5mm CoCr Rod, 40mm
008490440362753.5mm CoCr Rod, 240mm
008490440362683.5mm CoCr Rod, 120mm
008490440362513.5mm CoCr Rod, 80mm
008490440354904.5mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
008490440354834.5mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
008490440354764.0mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
008490440354694.0mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
008490440354523.5mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
008490440354453.5mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
008490440354383.5mm ELLIPSE Non-Fluted Polyaxial Screw, 8mm
00849044035421Lateral Connector, Closed, 20mm
00849044035414Lateral Connector, Closed, 15mm
00849044035407ELLIPSE Head Lateral Connector, 20mm
00849044035391ELLIPSE Head Lateral Connector, 15mm
00849044035384ELLIPSE Lateral Connector, Angled
00849044035377Occipital Jointed Rod, Left
00849044035360Occipital Jointed Rod, Right
00849044035353TL U-Clamp, 3.5mm Rod, Right
00849044035346TL U-Clamp, 3.5mm Rod, Left
00849044035339CT U-Clamp, 6.35mm Rod, Right
00849044035322CT U-Clamp, 6.35mm Rod, Left
00849044035315CT U-Clamp, 5.5mm Rod, Right
00849044035308CT U-Clamp, 5.5mm Rod, Left
00849044035292Offset Extension TL Clamp, 3.5mm Rod, Right
00849044035285Offset Extension TL Clamp, 3.5mm Rod, Left
00849044035278Offset Extension CT Clamp, 6.35mm Rod, Right
00849044035261Offset Extension CT Clamp, 6.35mm Rod, Left
00849044035254Offset Extension CT Clamp, 5.5mm Rod, Right
00849044035247Offset Extension CT Clamp, 5.5mm Rod, Left
00849044035230In-Line Extension CT Clamp, 3.5mm Rod, Right
00849044035223In-Line Extension CT Clamp, 3.5mm Rod, Left
00849044035216Parallel Connector Clamp, Double, CT to TL, 10mm
00849044035209Parallel Connector Clamp, Double, CT to CT, 9mm
00849044035193Parallel Connector Clamp, CT to TL, 10mm
00849044035186Parallel Connector Clamp, CT to CT, 9mm
00849044035179Rod-to-Rod Clamp, Double, CT to TL, 10mm
00849044035162Rod-to-Rod Clamp, CT to TL, 10mm

Trademark Results [ELLIPSE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELLIPSE
ELLIPSE
98135926 not registered Live/Pending
Capnova S.A.S.
2023-08-16
ELLIPSE
ELLIPSE
97876535 not registered Live/Pending
Wavegate Corporation
2023-04-06
ELLIPSE
ELLIPSE
97824486 not registered Live/Pending
Harmonic Egg, LLC
2023-03-06
ELLIPSE
ELLIPSE
97324461 not registered Live/Pending
Conair LLC
2022-03-22
ELLIPSE
ELLIPSE
90197271 not registered Live/Pending
Suncast Corporation
2020-09-21
ELLIPSE
ELLIPSE
90010898 not registered Live/Pending
Doctor Fashion, S.A.P.I. de CV
2020-06-19
ELLIPSE
ELLIPSE
88660814 not registered Live/Pending
TELEVES, S.A.
2019-10-18
ELLIPSE
ELLIPSE
87313964 not registered Live/Pending
Velo Labs Inc.
2017-01-25
ELLIPSE
ELLIPSE
86114993 4791293 Live/Registered
EFTON MANAGEMENT, INC.
2013-11-11
ELLIPSE
ELLIPSE
85715347 not registered Dead/Abandoned
Ellipse Technologies, Inc.
2012-08-28
ELLIPSE
ELLIPSE
85424248 not registered Dead/Abandoned
Ainsworth Game Technology Limited
2011-09-16
ELLIPSE
ELLIPSE
85392028 4169296 Live/Registered
Pacesetter, Inc.
2011-08-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.