CANOPY

GUDID 00193982314545

CANOPY Shelf Plate, 2.5mm Offset, Left, Inline, 7mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00193982314545
• NIH Device Record Key: 88d58c59-e432-4297-88d7-56f3842f49cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANOPY
• Version Model Number: 1102.3107
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982314545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121732

FDA Product Code

• NQW: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Sterilization

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

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

[00193982314545]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-27
• Device Publish Date: 2021-01-19

On-Brand Devices [CANOPY]

• 00889095027945: Graft Screw
• 00889095027938: CANOPY 3.0mm Screw, Self-Tapping, 12mm
• 00889095027921: CANOPY 3.0mm Screw, Self-Tapping, 10mm
• 00889095027914: CANOPY 3.0mm Screw, Self-Tapping, 8mm
• 00889095027907: CANOPY 3.0mm Screw, Self-Tapping, 6mm
• 00889095027891: CANOPY 3.0mm Screw, Self-Tapping, 5mm
• 00889095027884: CANOPY 3.0mm Screw, Self-Tapping, 4mm
• 00889095027877: CANOPY Hinge Plate, Adjacent
• 00889095027860: CANOPY Hinge Plate, In-line
• 00889095027853: CANOPY 2.6mm Screw, Self-Drilling, 12mm
• 00889095027846: CANOPY 2.6mm Screw, Self-Drilling, 10mm
• 00889095027839: CANOPY 2.6mm Screw, Self-Drilling, 8mm
• 00889095027822: CANOPY 2.6mm Screw, Self-Drilling, 6mm
• 00889095027815: CANOPY 2.6mm Screw, Self-Drilling, 5mm
• 00889095027808: CANOPY 2.6mm Screw, Self-Drilling, 4mm
• 00889095027792: CANOPY Polyaxial Screw Hole Plate, 13mm
• 00889095027785: CANOPY Polyaxial Screw Hole Plate, 11mm
• 00889095027778: CANOPY Polyaxial Screw Hole Plate, 9mm
• 00889095027761: CANOPY Polyaxial Screw Hole Plate, 7mm
• 00889095027754: CANOPY Polyaxial Screw Hole Plate, 5mm
• 00889095027747: CANOPY Shelf Plate, Adjacent, 13mm
• 00889095027730: CANOPY Shelf Plate, Adjacent, 11mm
• 00889095027723: CANOPY Shelf Plate, Adjacent, 9mm
• 00889095027716: CANOPY Shelf Plate, Adjacent, 7mm
• 00889095027709: CANOPY Shelf Plate, Adjacent, 5mm
• 00889095027693: CANOPY Shelf Plate, In-line, 13mm
• 00889095027686: CANOPY Shelf Plate, In-line, 11mm
• 00889095027679: CANOPY Shelf Plate, In-line, 9mm
• 00889095027662: CANOPY Shelf Plate, In-line, 7mm
• 00889095027655: CANOPY Shelf Plate, In-line, 5mm
• 00889095027648: CANOPY Graft Plate, Adjacent, 13mm
• 00889095027631: CANOPY Graft Plate, Adjacent, 11mm
• 00889095027624: CANOPY Graft Plate, Adjacent, 9mm
• 00889095027617: CANOPY Graft Plate, Adjacent, 7mm
• 00889095027600: CANOPY Graft Plate, Adjacent, 5mm
• 00889095027594: CANOPY Graft Plate, In-line, 13mm
• 00889095027587: CANOPY Graft Plate, In-line, 11mm
• 00889095027570: CANOPY Graft Plate, In-line, 9mm
• 00889095027563: CANOPY Graft Plate, In-line, 7mm
• 00889095027556: CANOPY Graft Plate, In-line, 5mm
• 00193982314729: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 13mm
• 00193982314712: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 11mm
• 00193982314705: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 9mm
• 00193982314699: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 7mm
• 00193982314682: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Right, 5mm
• 00193982314675: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Left, 13mm
• 00193982314668: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Left, 11mm
• 00193982314651: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Left, 9mm
• 00193982314644: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Left, 7mm
• 00193982314637: CANOPY Polyaxial Screw Hole Plate, 2.5mm Offset, Left, 5mm