COALITION

GUDID 00889095057317

COALITION ACDF Trial, 12° Lordotic , 12x14 - 10mm

GLOBUS MEDICAL, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889095057317
• NIH Device Record Key: d9d4b2a3-4c1c-471d-b8a7-5d3b125ee236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COALITION
• Version Model Number: 684.730
• 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: false
• 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
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Depth: 12 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095057317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131449

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

[00889095057317]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-07

On-Brand Devices [COALITION]

• 00849044093247: COALITION Spacer, 15mm x 18mm, 7deg, 5mm
• 00849044093230: COALITION Spacer, 15mm x 18mm, 0deg, 5mm
• 00849044093223: COALITION Spacer, 14mm x 16mm, 7deg, 5mm
• 00849044093216: COALITION Spacer, 14mm x 16mm, 0deg, 5mm
• 00849044093209: COALITION Spacer, 12mm x 14mm, 7deg, 5mm
• 00849044093193: COALITION Spacer, 12mm x 14mm, 0deg, 5mm
• 00849044027877: COALITION Spacer, 15mm x 18mm, 7deg, 12mm
• 00849044027860: COALITION Spacer, 15mm x 18mm, 7deg, 11mm
• 00849044027853: COALITION Spacer, 15mm x 18mm, 7deg, 10mm
• 00849044027846: COALITION Spacer, 15mm x 18mm, 7deg, 9mm
• 00849044027839: COALITION Spacer, 15mm x 18mm, 7deg, 8mm
• 00849044027822: COALITION Spacer, 15mm x 18mm, 7deg, 7mm
• 00849044027815: COALITION Spacer, 15mm x 18mm, 7deg, 6mm
• 00849044027808: COALITION Spacer, 15mm x 18mm, 0deg, 12mm
• 00849044027792: COALITION Spacer, 15mm x 18mm, 0deg, 11mm
• 00849044027785: COALITION Spacer, 15mm x 18mm, 0deg, 10mm
• 00849044027778: COALITION Spacer, 15mm x 18mm, 0deg, 9mm
• 00849044027761: COALITION Spacer, 15mm x 18mm, 0deg, 8mm
• 00849044027754: COALITION Spacer, 15mm x 18mm, 0deg, 7mm
• 00849044027747: COALITION Spacer, 15mm x 18mm, 0deg, 6mm
• 00849044027730: COALITION Spacer, 14mm x 16mm, 7°, 12mm
• 00849044027723: COALITION Spacer, 14mm x 16mm, 7deg, 11mm
• 00849044027716: COALITION Spacer, 14mm x 16mm, 7deg, 10mm
• 00849044027709: COALITION Spacer, 14mm x 16mm, 7deg, 9mm
• 00849044027693: COALITION Spacer, 14mm x 16mm, 7deg, 8mm
• 00849044027686: COALITION Spacer, 14mm x 16mm, 7deg, 7mm
• 00849044027679: COALITION Spacer, 14mm x 16mm, 7deg, 6mm
• 00849044027662: COALITION Spacer, 14mm x 16mm, 0deg, 12mm
• 00849044027655: COALITION Spacer, 14mm x 16mm, 0deg, 11mm
• 00849044027648: COALITION Spacer, 14mm x 16mm, 0deg, 10mm
• 00849044027631: COALITION Spacer, 14mm x 16mm, 0deg, 9mm
• 00849044027624: COALITION Spacer, 14mm x 16mm, 0deg, 8mm
• 00849044027617: COALITION Spacer, 14mm x 16mm, 0deg, 7mm
• 00849044027600: COALITION Spacer, 14mm x 16mm, 0deg, 6mm
• 00849044027594: COALITION Spacer, 16mm x 20mm, 7deg, 12mm
• 00849044027587: COALITION Spacer, 16mm x 20mm, 7deg, 11mm
• 00849044027570: COALITION Spacer, 16mm x 20mm, 7deg, 10mm
• 00849044027563: COALITION Spacer, 16mm x 20mm, 7deg, 9mm
• 00849044027556: COALITION Spacer, 16mm x 20mm, 7deg, 8mm
• 00849044027549: COALITION Spacer, 16mm x 20mm, 7deg, 7mm
• 00849044027532: COALITION Spacer, 16mm x 20mm, 7deg, 6mm
• 00849044027525: COALITION Spacer, 16mm x 14mm, 7deg, 12mm
• 00849044027518: COALITION Spacer, 16mm x 14mm, 7deg, 11mm
• 00849044027501: COALITION Spacer, 16mm x 14mm, 7deg, 10mm
• 00849044027495: COALITION Spacer, 16mm x 14mm, 7deg, 9mm
• 00849044027488: COALITION Spacer, 16mm x 14mm, 7deg, 8mm
• 00849044027471: COALITION Spacer, 16mm x 14mm, 7deg, 7mm
• 00849044027464: COALITION Spacer, 16mm x 14mm, 7deg, 6mm
• 00849044027457: COALITION Spacer, 14mm x 14mm, 7deg, 12mm
• 00849044027440: COALITION Spacer, 14mm x 14mm, 7deg, 11mm