ROMEO posterior osteosynthesis system ELL-R8 15 00-N

GUDID 07640178971462

ROD COBALT CHROMIUM / PREBENT

SpineArt SA

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 07640178971462
• NIH Device Record Key: 8a710e78-faad-4690-83a3-8cf8154bb08e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROMEO posterior osteosynthesis system
• Version Model Number: ELL-R8 15 00-N
• Catalog Number: ELL-R8 15 00-N
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter
• Angle: 80 degree
• Outer Diameter: 5.4 Millimeter
• Length: 500 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640178971462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141835

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

[07640178971462]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-03

On-Brand Devices [ROMEO posterior osteosynthesis system]

• 07640178981980: PERCUTANEOUS PRE-BENT ROD
• 07640178981966: Titanium pre-bent longitudinal rod
• 07640178981904: PERCUTANEOUS PRE-BENT ROD
• 07640178981881: Titanium pre-bent longitudinal rod
• 07640178973824: HEXALOBE SETSCREW
• 07640178973725: ROD CONNECTOR PARALLEL O/O
• 07640178973701: T-CONNECTOR
• 07640178973527: FIX ROD BENDER
• 07640178972872: PADDLE DISTRACTOR
• 07640178972865: PADDLE DISTRACTOR
• 07640178972858: PADDLE DISTRACTOR
• 07640178972841: PADDLE DISTRACTOR
• 07640178972568: RASP TRIAL H08
• 07640178972452: SENSOR CLAMP. NAV.
• 07640178972445: SMALL PEDICLE PROBE. NAV.
• 07640178972438: PEDICLE PROBE. NAV.
• 07640178972421: BONE AWL. NAV.
• 07640178972407: SCREWDRIVER SHAFT PS NAV.
• 07640178972391: SCREWDRIVER SHAFT SS. NAV.
• 07640178972384: SCREWDRIVER SHAFT MS. NAV.
• 07640178972377: TROCAR 3 IN 1 / HANDLE. NAV.
• 07640178972339: PEDICLE PROBE. NAV.
• 07640178972322: SCREWDRIVER SHAFT PS CANNULATED. NAV.
• 07640178972117: TAB BREAKER
• 07640178972094: SQUARE AWL BAYONETED
• 07640178971479: ROD COBALT CHROMIUM / PREBENT
• 07640178971462: ROD COBALT CHROMIUM / PREBENT
• 07640178971455: ROD COBALT CHROMIUM / PREBENT
• 07640178971448: ROD COBALT CHROMIUM / PREBENT
• 07640178971431: ROD COBALT CHROMIUM / PREBENT
• 07640178971424: ROD COBALT CHROMIUM / PREBENT
• 07640178971417: ROD COBALT CHROMIUM / PREBENT
• 07640178971400: ROD COBALT CHROMIUM / PREBENT
• 07640178971394: ROD COBALT CHROMIUM / PREBENT
• 07640178971387: ROD COBALT CHROMIUM / PREBENT
• 07640178971370: ROD COBALT CHROMIUM / PREBENT
• 07640178971363: ROD COBALT CHROMIUM / PREBENT
• 07640178971356: ROD COBALT CHROMIUM / PREBENT
• 07640178971349: ROD COBALT CHROMIUM / PREBENT
• 07640178971301: Rod Cobalt Chromium / Prebent
• 07640178971295: Rod Cobalt Chromium / Prebent
• 07640178971288: Rod Cobalt Chromium / Prebent
• 07640178971271: Rod Cobalt Chromium / Prebent
• 07640178971264: Rod Cobalt Chromium / Prebent
• 07640178971257: Rod Cobalt Chromium / Prebent
• 07640178971240: Rod Cobalt Chromium / Prebent
• 07640178971233: Rod Cobalt Chromium / Prebent
• 07640178971226: Rod Cobalt Chromium / Prebent
• 07640178971219: Rod Cobalt Chromium / Prebent
• 07640178971202: Rod Cobalt Chromium / Prebent