COLOSSEUM

GUDID 00889095977011

COLOSSEUM Mesh, 21x23mm, 80mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095977011
• NIH Device Record Key: 0ebd73ca-f5fb-4571-812a-1601022ea33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLOSSEUM
• Version Model Number: 156.720
• 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 Dimensions

• Height: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095977011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190147

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00889095977011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-12-25

On-Brand Devices [COLOSSEUM]

• 00889095977417: COLOSSEUM Endcap, 25x30mm, 12mm, 12°
• 00889095977400: COLOSSEUM Endcap, 25x30mm, 10mm, 12°
• 00889095977394: COLOSSEUM Endcap, 25x30mm, 8mm, 12°
• 00889095977387: COLOSSEUM Endcap, 25x30mm, 10mm, 8°
• 00889095977370: COLOSSEUM Endcap, 25x30mm, 8mm, 8°
• 00889095977363: COLOSSEUM Endcap, 25x30mm, 6mm, 8°
• 00889095977356: COLOSSEUM Endcap, 25x30mm, 8mm, 4°
• 00889095977349: COLOSSEUM Endcap, 25x30mm, 6mm, 4°
• 00889095977332: COLOSSEUM Endcap, 25x30mm, 4mm, 4°
• 00889095977325: COLOSSEUM Endcap, 25x30mm, 6mm, 0°
• 00889095977318: COLOSSEUM Endcap, 25x30mm, 4mm, 0°
• 00889095977301: COLOSSEUM Endcap, 25x30mm, 2mm, 0°
• 00889095977295: COLOSSEUM Mesh, 25x30mm, 148mm
• 00889095977288: COLOSSEUM Mesh, 25x30mm, 120mm
• 00889095977271: COLOSSEUM Mesh, 25x30mm, 80mm
• 00889095977264: COLOSSEUM Mesh, 25x30mm, 60mm
• 00889095977257: COLOSSEUM Mesh, 25x30mm, 48mm
• 00889095977240: COLOSSEUM Mesh, 25x30mm, 44mm
• 00889095977233: COLOSSEUM Mesh, 25x30mm, 40mm
• 00889095977226: COLOSSEUM Mesh, 25x30mm, 36mm
• 00889095977219: COLOSSEUM Mesh, 25x30mm, 32mm
• 00889095977202: COLOSSEUM Mesh, 25x30mm, 28mm
• 00889095977196: COLOSSEUM Mesh, 25x30mm, 24mm
• 00889095977189: COLOSSEUM Mesh, 25x30mm, 20mm
• 00889095977172: COLOSSEUM Mesh, 25x30mm, 16mm
• 00889095977165: COLOSSEUM Mesh, 25x30mm, 12mm
• 00889095977158: COLOSSEUM Mesh, 25x30mm, 8mm
• 00889095977141: COLOSSEUM Endcap, 21x23mm, 8mm, 12°
• 00889095977134: COLOSSEUM Endcap, 21x23mm, 6mm, 12°
• 00889095977127: COLOSSEUM Endcap, 21x23mm, 8mm, 8°
• 00889095977110: COLOSSEUM Endcap, 21x23mm, 6mm, 8°
• 00889095977103: COLOSSEUM Endcap, 21x23mm, 4mm, 8°
• 00889095977097: COLOSSEUM Endcap, 21x23mm, 8mm, 4°
• 00889095977080: COLOSSEUM Endcap, 21x23mm, 6mm, 4°
• 00889095977073: COLOSSEUM Endcap, 21x23mm, 4mm, 4°
• 00889095977066: COLOSSEUM Endcap, 21x23mm, 6mm, 0°
• 00889095977059: COLOSSEUM Endcap, 21x23mm, 4mm, 0°
• 00889095977042: COLOSSEUM Endcap, 21x23mm, 2mm, 0°
• 00889095977035: COLOSSEUM Mesh, 21x23mm, 148mm
• 00889095977028: COLOSSEUM Mesh, 21x23mm, 120mm
• 00889095977011: COLOSSEUM Mesh, 21x23mm, 80mm
• 00889095977004: COLOSSEUM Mesh, 21x23mm, 60mm
• 00889095976991: COLOSSEUM Mesh, 21x23mm, 48mm
• 00889095976984: COLOSSEUM Mesh, 21x23mm, 44mm
• 00889095976977: COLOSSEUM Mesh, 21x23mm, 40mm
• 00889095976960: COLOSSEUM Mesh, 21x23mm, 36mm
• 00889095976953: COLOSSEUM Mesh, 21x23mm, 32mm
• 00889095976946: COLOSSEUM Mesh, 21x23mm, 28mm
• 00889095976939: COLOSSEUM Mesh, 21x23mm, 24mm
• 00889095976922: COLOSSEUM Mesh, 21x23mm, 20mm