ELLIPSE Lumbar posterior osteosynthesis system

GUDID 07640139341570

Pre-Bent Rod

SpineArt SA

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07640139341570
• NIH Device Record Key: 287ef681-d887-4d54-8f1e-539734df41d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELLIPSE Lumbar posterior osteosynthesis system
• Version Model Number: ELL-RD 00 90-S
• Company DUNS: 483016148
• Company Name: SpineArt SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 90 Millimeter
• Outer Diameter: 5.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640139341570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081165

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-08
• Device Publish Date: 2015-10-21

On-Brand Devices [ELLIPSE Lumbar posterior osteosynthesis system]

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