RAVINE® Lateral Access System SP-4110

GUDID 10888857465640

Dilator, Size 6 mm

K2M, INC.

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• Primary Device ID: 10888857465640
• NIH Device Record Key: 97e58aaa-7154-4fa1-8879-5326e644e0f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAVINE® Lateral Access System
• Version Model Number: SP-4110
• Catalog Number: SP-4110
• Company DUNS: 146060863
• Company Name: K2M, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com

Device Dimensions

• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter
• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857465640 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

[10888857465640]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-20
• Device Publish Date: 2019-12-12

On-Brand Devices [RAVINE® Lateral Access System]

• 10888857465640: Dilator, Size 6 mm
• 10888857486928: ACDF Retractor Frame
• 10888857243934: Lateral Access Blade Extender,
• 10888857036048: Lateral Access Blade, Size 18x200 mm
• 10888857036031: Lateral Access Blade, Size 18x190 mm
• 10888857036024: Lateral Access Blade, Size 18x180 mm
• 10888857036017: Lateral Access Blade, Size 18x170 mm
• 10888857036000: Lateral Access Blade, Size 18x160 mm
• 10888857035997: Lateral Access Blade, Size 18x150 mm
• 10888857035980: Lateral Access Blade, Size 18x140 mm
• 10888857035973: Lateral Access Blade, Size 18x130 mm
• 10888857035966: Lateral Access Blade, Size 18x120 mm
• 10888857035959: Lateral Access Blade, Size 18x110 mm
• 10888857035942: Lateral Access Blade, Size 18x100 mm
• 10888857035935: Lateral Access Blade, Size 18x90 mm
• 10888857035928: Lateral Access Blade, Size 18x80 mm
• 10888857035911: Lateral Access Blade, Size 18x70 mm
• 10888857035881: A/P Lateral Access Blade, Size 13x200 mm
• 10888857035874: A/P Lateral Access Blade, Size 13x190 mm
• 10888857035867: A/P Lateral Access Blade, Size 13x180 mm
• 10888857035850: A/P Lateral Access Blade, Size 13x170 mm
• 10888857035843: Lateral Access Blade, Size 24x200 mm
• 10888857035836: Lateral Access Blade, Size 24x190 mm
• 10888857035829: Lateral Access Blade, Size 24x180 mm
• 10888857035812: Lateral Access Blade, Size 24x170 mm
• 10888857035416: A/P Lateral Access Blade, Size 13x160 mm
• 10888857035409: A/P Lateral Access Blade, Size 13x150 mm
• 10888857035393: A/P Lateral Access Blade, Size 13x140 mm
• 10888857035386: A/P Lateral Access Blade, Size 13x130 mm
• 10888857035379: A/P Lateral Access Blade, Size 13x120 mm
• 10888857035362: A/P Lateral Access Blade, Size 13x110 mm
• 10888857035355: A/P Lateral Access Blade, Size 13x100 mm
• 10888857035348: A/P Lateral Access Blade, Size 13x90 mm
• 10888857035331: A/P Lateral Access Blade, Size 13x80 mm
• 10888857035324: A/P Lateral Access Blade, Size 13x70 mm
• 10888857035317: Lateral Access Blade, Size 24x160 mm
• 10888857035300: Lateral Access Blade, Size 24x150 mm
• 10888857035294: Lateral Access Blade, Size 24x140 mm
• 10888857035287: Lateral Access Blade, Size 24x130 mm
• 10888857035270: Lateral Access Blade, Size 24x120 mm
• 10888857035263: Lateral Access Blade, Size 24x110 mm
• 10888857035256: Lateral Access Blade, Size 24x100 mm
• 10888857035249: Lateral Access Blade, Size 24x90 mm
• 10888857035232: Lateral Access Blade, Size 24x80 mm
• 10888857035225: Lateral Access Blade, Size 24x70 mm
• 10888857457867: Gelpi Retractor
• 10888857457850: Fixation Pin, Size 210 mm
• 10888857457843: Fixation Pin, Size 200 mm
• 10888857457836: Fixation Pin, Size 190 mm
• 10888857457829: Fixation Pin, Size 180 mm