Meridian RA3-009021

GUDID 10889981284558

Meridian Implant Tray Level 1

SEASPINE ORTHOPEDICS CORPORATION

Instrument tray, reusable

• Primary Device ID: 10889981284558
• NIH Device Record Key: 80cf86d5-8522-4c92-b4e0-f472dac4cf29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meridian
• Version Model Number: RA3-009021
• Catalog Number: RA3-009021
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981284558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220711

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

[10889981284558]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

On-Brand Devices [Meridian]

• 10889981214272: Anterior Plate Locking Cover, 10mm
• 10889981259549: Spin Plate, 39mm x 30mm x 8mm
• 10889981259532: Spin Plate, 39mm x27mm x 8mm
• 10889981259525: Spin Plate, 35mm x 27mm x 8mm
• 10889981259518: Spin Plate, 31mm x 24mm x 8mm
• 10889981247676: Torque Limiting T-Handle, 29inlb
• 10889981247652: No-Profile Interbody, 43mm x 30mm x 20mm, 30 Deg
• 10889981247645: No-Profile Interbody, 43mm x 30mm x 20mm, 25 Deg
• 10889981247638: No-Profile Interbody, 43mm x 30mm x 20mm, 20 Deg
• 10889981247621: No-Profile Interbody, 43mm x 30mm x 20mm, 15 Deg
• 10889981247614: No-Profile Interbody, 43mm x 30mm x 20mm, 10 Deg
• 10889981247607: No-Profile Interbody, 43mm x 30mm x 18mm, 30 Deg
• 10889981247591: No-Profile Interbody, 43mm x 30mm x 18mm, 25 Deg
• 10889981247584: No-Profile Interbody, 43mm x 30mm x 18mm, 20 Deg
• 10889981247577: No-Profile Interbody, 43mm x 30mm x 18mm, 15 Deg
• 10889981247560: No-Profile Interbody, 43mm x 30mm x 18mm, 10 Deg
• 10889981247553: No-Profile Interbody, 43mm x 30mm x 16mm, 30 Deg
• 10889981247546: No-Profile Interbody, 43mm x 30mm x 16mm, 25 Deg
• 10889981247539: No-Profile Interbody, 43mm x 30mm x 16mm, 20 Deg
• 10889981247522: No-Profile Interbody, 43mm x 30mm x 16mm, 15 Deg
• 10889981247515: No-Profile Interbody, 43mm x 30mm x 16mm, 10 Deg
• 10889981247508: No-Profile Interbody, 43mm x 30mm x 14mm, 25 Deg
• 10889981247492: No-Profile Interbody, 43mm x 30mm x 14mm, 20 Deg
• 10889981247485: No-Profile Interbody, 43mm x 30mm x 14mm, 15 Deg
• 10889981247478: No-Profile Interbody, 43mm x 30mm x 14mm, 10 Deg
• 10889981247461: No-Profile Interbody, 43mm x 30mm x 12mm, 20 Deg
• 10889981247454: No-Profile Interbody, 43mm x 30mm x 12mm, 15 Deg
• 10889981247447: No-Profile Interbody, 43mm x 30mm x 12mm, 10 Deg
• 10889981247430: No-Profile Interbody, 43mm x 30mm x 10mm, 15 Deg
• 10889981247423: No-Profile Interbody, 43mm x 30mm x 10mm, 10 Deg
• 10889981247416: No-Profile Interbody, 39mm x 30mm x 20mm, 30 Deg
• 10889981247409: No-Profile Interbody, 39mm x 30mm x 20mm, 20 Deg
• 10889981247393: No-Profile Interbody, 39mm x 30mm x 20mm, 15 Deg
• 10889981247386: No-Profile Interbody, 39mm x 30mm x 20mm, 10 Deg
• 10889981247379: No-Profile Interbody, 39mm x 30mm x 18mm, 30 Deg
• 10889981247362: No-Profile Interbody, 39mm x 30mm x 18mm, 15 Deg
• 10889981247355: No-Profile Interbody, 39mm x 30mm x 18mm, 10 Deg
• 10889981247348: No-Profile Interbody, 39mm x 30mm x 16mm, 30 Deg
• 10889981247331: No-Profile Interbody, 39mm x 30mm x 16mm, 25 Deg
• 10889981247324: No-Profile Interbody, 39mm x 30mm x 14mm, 25 Deg
• 10889981247317: No-Profile Interbody, 39mm x 30mm x 12mm, 20 Deg
• 10889981247300: No-Profile Interbody, 39mm x 30mm x 10mm, 15 Deg
• 10889981247294: No-Profile Interbody, 39mm x 27mm x 20mm, 30 Deg
• 10889981247287: No-Profile Interbody, 39mm x 27mm x 20mm, 20 Deg
• 10889981247270: No-Profile Interbody, 39mm x 27mm x 20mm, 15 Deg
• 10889981247263: No-Profile Interbody, 39mm x 27mm x 20mm, 10 Deg
• 10889981247256: No-Profile Interbody, 39mm x 27mm x 18mm, 30 Deg
• 10889981247249: No-Profile Interbody, 39mm x 27mm x 18mm, 15 Deg
• 10889981247232: No-Profile Interbody, 39mm x 27mm x 18mm, 10 Deg
• 10889981247225: No-Profile Interbody, 39mm x 27mm x 16mm, 30 Deg