ELLIPSE Lumbar posterior osteosynthesis system

GUDID 07640139341686

Reduction Screw

SpineArt SA

Bone-screw internal spinal fixation system, sterile
Primary Device ID07640139341686
NIH Device Record Keyee588f69-3a3d-4acb-b4ff-eb37718e6ac3
Commercial Distribution StatusIn Commercial Distribution
Brand NameELLIPSE Lumbar posterior osteosynthesis system
Version Model NumberELL-SS 05 30-S
Company DUNS483016148
Company NameSpineArt SA
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter
Length30 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640139341686 [Primary]

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-08
Device Publish Date2015-10-22

On-Brand Devices [ELLIPSE Lumbar posterior osteosynthesis system]

07640178973831Hexalobe Setscrew
07640178973732Rod Connector parrallel O/O
07640178973718T-connector
07640151093839Hexalobe Setscrew
07640151093730Rod Connector parrallel O/O
07640151093716T-connector
07640139341815Reduction Screw
07640139341808Reduction Screw
07640139341792Reduction Screw
07640139341785Reduction Screw
07640139341778Reduction Screw
07640139341761Reduction Screw
07640139341754Reduction Screw
07640139341747Reduction Screw
07640139341730Reduction Screw
07640139341723Reduction Screw
07640139341716Reduction Screw
07640139341709Reduction Screw
07640139341693Reduction Screw
07640139341686Reduction Screw
07640139341679Transverse Connector
07640139341662Transverse Rod
07640139341655Transverse Rod
07640139341648Transverse Rod
07640139341631Transverse Rod
07640139341624Pre-Bent Rod
07640139341617Pre-Bent Rod
07640139341600Pre-Bent Rod
07640139341594Pre-Bent Rod
07640139341587Pre-Bent Rod
07640139341570Pre-Bent Rod
07640139341563Pre-Bent Rod
07640139341556Pre-Bent Rod
07640139341549Pre-Bent Rod
07640139341532Pre-Bent Rod
07640139341525Pre-Bent Rod
07640139341518Pre-Bent Rod
07640139341501Setscrew
07640139341495Polyaxial Screw
07640139341488Polyaxial Screw
07640139341471Polyaxial Screw
07640139341464Polyaxial Screw
07640139341457Polyaxial Screw
07640139341440Polyaxial Screw
07640139341433Polyaxial Screw
07640139341426Polyaxial Screw
07640139341419Polyaxial Screw
07640139341402Polyaxial Screw
07640139341396Polyaxial Screw
07640139341389Polyaxial Screw

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