ELLIPSE

GUDID 00849044035438

3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 8mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00849044035438
• NIH Device Record Key: 5dd21964-de8d-4fb6-a176-3aae8cfd83b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELLIPSE
• Version Model Number: 582.308
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044035438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090565

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00849044035438]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-07

On-Brand Devices [ELLIPSE]

• 00849044036404: CoCr Tapered Rod, 3.5mm to 5.5mm, 500mm
• 00849044036398: CoCr Tapered Rod, 3.5mm to 6.5mm, 350mm
• 00849044036381: CoCr Tapered Rod, 3.5mm to 6.35mm, 350mm
• 00849044036374: CoCr Tapered Rod, 3.5mm to 6.0mm, 350mm
• 00849044036367: CoCr Tapered Rod, 3.5mm to 5.5mm, 350mm
• 00849044036350: CoCr Tapered Rod, 3.5mm to 5.0mm, 350mm
• 00849044036343: CoCr Tapered Rod, 3.5mm to 4.5mm, 350mm
• 00849044036336: CoCr Tapered Rod, 3.5mm to 4.0mm, 350mm
• 00849044036329: CoCr Tapered Rod, 3.5mm to 3.7mm, 350mm
• 00849044036312: 3.5mm CoCr Occipital Rod 240mm, 130°
• 00849044036305: 3.5mm CoCr Occipital Rod 240mm, 115°
• 00849044036299: 3.5mm CoCr Occipital Rod 240mm, 100°
• 00849044036282: 3.5mm CoCr Rod, 40mm
• 00849044036275: 3.5mm CoCr Rod, 240mm
• 00849044036268: 3.5mm CoCr Rod, 120mm
• 00849044036251: 3.5mm CoCr Rod, 80mm
• 00849044035490: 4.5mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
• 00849044035483: 4.5mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
• 00849044035476: 4.0mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
• 00849044035469: 4.0mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
• 00849044035452: 3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 12mm
• 00849044035445: 3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 10mm
• 00849044035438: 3.5mm ELLIPSE Non-Fluted Polyaxial Screw, 8mm
• 00849044035421: Lateral Connector, Closed, 20mm
• 00849044035414: Lateral Connector, Closed, 15mm
• 00849044035407: ELLIPSE Head Lateral Connector, 20mm
• 00849044035391: ELLIPSE Head Lateral Connector, 15mm
• 00849044035384: ELLIPSE Lateral Connector, Angled
• 00849044035377: Occipital Jointed Rod, Left
• 00849044035360: Occipital Jointed Rod, Right
• 00849044035353: TL U-Clamp, 3.5mm Rod, Right
• 00849044035346: TL U-Clamp, 3.5mm Rod, Left
• 00849044035339: CT U-Clamp, 6.35mm Rod, Right
• 00849044035322: CT U-Clamp, 6.35mm Rod, Left
• 00849044035315: CT U-Clamp, 5.5mm Rod, Right
• 00849044035308: CT U-Clamp, 5.5mm Rod, Left
• 00849044035292: Offset Extension TL Clamp, 3.5mm Rod, Right
• 00849044035285: Offset Extension TL Clamp, 3.5mm Rod, Left
• 00849044035278: Offset Extension CT Clamp, 6.35mm Rod, Right
• 00849044035261: Offset Extension CT Clamp, 6.35mm Rod, Left
• 00849044035254: Offset Extension CT Clamp, 5.5mm Rod, Right
• 00849044035247: Offset Extension CT Clamp, 5.5mm Rod, Left
• 00849044035230: In-Line Extension CT Clamp, 3.5mm Rod, Right
• 00849044035223: In-Line Extension CT Clamp, 3.5mm Rod, Left
• 00849044035216: Parallel Connector Clamp, Double, CT to TL, 10mm
• 00849044035209: Parallel Connector Clamp, Double, CT to CT, 9mm
• 00849044035193: Parallel Connector Clamp, CT to TL, 10mm
• 00849044035186: Parallel Connector Clamp, CT to CT, 9mm
• 00849044035179: Rod-to-Rod Clamp, Double, CT to TL, 10mm
• 00849044035162: Rod-to-Rod Clamp, CT to TL, 10mm