COLONIAL

GUDID 00889095237306

COLONIAL ACDF TPS Spacer, 11x12, 7°, 10mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095237306
• NIH Device Record Key: d0cf99c3-b9fa-4349-878d-a55f6f4a301f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLONIAL
• Version Model Number: 365.110CS
• 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: true
• 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: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095237306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143578

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-08

On-Brand Devices [COLONIAL]

• 00849044029604: Colonial ACDF Spacer Body, X-Large, Parallel, 12mm
• 00849044029598: Colonial ACDF Spacer Body, X-Large, Parallel, 11mm
• 00849044029581: Colonial ACDF Spacer Body, X-Large, Parallel, 10mm
• 00849044029574: Colonial ACDF Spacer Body, X-Large, Parallel, 9mm
• 00849044029567: Colonial ACDF Spacer Body, X-Large, Parallel, 8mm
• 00849044029550: Colonial ACDF Spacer Body, X-Large, Parallel, 7mm
• 00849044029543: Colonial ACDF Spacer Body, X-Large, Parallel, 6mm
• 00849044029536: Colonial ACDF Spacer Body, X-Large, Parallel, 5mm
• 00849044029529: Colonial ACDF Spacer Body, X-Large, Lordotic, 12mm
• 00849044029512: Colonial ACDF Spacer Body, X-Large, Lordotic, 11mm
• 00849044029505: Colonial ACDF Spacer Body, X-Large, Lordotic, 10mm
• 00849044029499: Colonial ACDF Spacer Body, X-Large, Lordotic, 9mm
• 00849044029482: Colonial ACDF Spacer Body, X-Large, Lordotic, 8mm
• 00849044029475: Colonial ACDF Spacer Body, X-Large, Lordotic, 7mm
• 00849044029468: Colonial ACDF Spacer Body, X-Large, Lordotic, 6mm
• 00849044029451: Colonial ACDF Spacer Body, X-Large, Lordotic, 5mm
• 00849044029444: Colonial ACDF Spacer, Large, Lordotic, 12mm
• 00849044029437: Colonial ACDF Spacer, Large, Lordotic, 11mm
• 00849044029420: Colonial ACDF Spacer, Large, Lordotic, 10mm
• 00849044029413: Colonial ACDF Spacer, Large, Lordotic, 9mm
• 00849044029406: Colonial ACDF Spacer, Large, Lordotic, 8mm
• 00849044029390: Colonial ACDF Spacer, Large, Lordotic, 7mm
• 00849044029383: Colonial ACDF Spacer, Large, Lordotic, 6mm
• 00849044029376: Colonial ACDF Spacer, Large, Lordotic, 5mm
• 00849044029369: Colonial ACDF Spacer, Large, Parallel, 12mm
• 00849044029352: Colonial ACDF Spacer, Large, Parallel, 11mm
• 00849044029345: Colonial ACDF Spacer, Large, Parallel, 10mm
• 00849044029338: Colonial ACDF Spacer, Large, Parallel, 9mm
• 00849044029321: Colonial ACDF Spacer, Large, Parallel, 8mm
• 00849044029314: Colonial ACDF Spacer, Large, Parallel, 7mm
• 00849044029307: Colonial ACDF Spacer, Large, Parallel, 6mm
• 00849044029291: Colonial ACDF Spacer, Large, Parallel, 5mm
• 00849044029284: Colonial ACDF Spacer,Small, Lordotic, 12mm
• 00849044029277: Colonial ACDF Spacer, Small, Lordotic, 11mm
• 00849044029260: Colonial ACDF Spacer, Small, Lordotic, 10mm
• 00849044029253: Colonial ACDF Spacer, Small, Lordotic, 9mm
• 00849044029246: Colonial ACDF Spacer, Small, Lordotic, 8mm
• 00849044029239: Colonial ACDF Spacer, Small, Lordotic, 7mm
• 00849044029222: Colonial ACDF Spacer, Small, Lordotic, 6mm
• 00849044029215: Colonial ACDF Spacer, Small, Lordotic, 5mm
• 00849044029208: COLONIAL ACDF Spacer, XX-Large, Lordotic, 12mm
• 00849044029192: COLONIAL ACDF Spacer, XX-Large, Lordotic, 11mm
• 00849044029185: COLONIAL ACDF Spacer, XX-Large, Lordotic, 10mm
• 00849044029178: COLONIAL ACDF Spacer, XX-Large, Lordotic, 9mm
• 00849044029161: COLONIAL ACDF Spacer, XX-Large, Lordotic, 8mm
• 00849044029154: COLONIAL ACDF Spacer, XX-Large, Lordotic, 7mm
• 00849044029147: COLONIAL ACDF Spacer, XX-Large, Lordotic, 6mm
• 00849044029130: COLONIAL ACDF Spacer, XX-Large, Lordotic, 5mm
• 00849044029123: COLONIAL ACDF Spacer, XX-Large, Parallel, 12mm
• 00849044029116: COLONIAL ACDF Spacer, XX-Large, Parallel, 11mm