Coral CORDEF2IMP

GUDID 10889981028107

CORAL® DEFORMITY IMPLANTS 1. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal

Seaspine, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981028107
• NIH Device Record Key: 9baaad95-120c-47ba-ac56-30aa1ace9e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coral
• Version Model Number: CORDEF2IMP
• Catalog Number: CORDEF2IMP
• Company DUNS: 119614407
• Company Name: Seaspine, 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: true
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981028107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041592

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

[10889981028107]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

Devices Manufactured by Seaspine, Inc.

• M5567070351 - Malibu: 2021-08-09 TSC Uni-Planar Screw 7.0 x 35mm
• 10889981028107 - Coral: 2018-07-06CORAL® DEFORMITY IMPLANTS 1. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal
• 10889981028107 - Coral: 2018-07-06 CORAL® DEFORMITY IMPLANTS 1. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and conne