Coral 10-10-5535

GUDID 10889981013417

Fixed Screw 5.50mm x 35mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981013417
• NIH Device Record Key: a3054006-85ba-4240-b445-87e21da51408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coral
• Version Model Number: 10-10-5535
• Catalog Number: 10-10-5535
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981013417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041592

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

Moist Heat or Steam Sterilization

[10889981013417]

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

On-Brand Devices [Coral]

• 10889981140106: CORAL FRICTION INSTRUMENTS 2
• 10889981136697: Locking Screw Caddy Base
• 10889981136680: Deformity Implant Case Lid
• 10889981136673: Base
• 10889981136666: Lower level-screws & rods
• 10889981136659: Hooks tray level
• 10889981136642: Locking Screw Caddy Lid
• 10889981136635: Coral Instrument Case Lid
• 10889981136628: Case Assembly
• 10889981136611: Inner Tray level-lower
• 10889981136604: Inner Tray level-middle
• 10889981136598: Inner Tray Level-Top
• 10889981136581: Coral Instrument Case Lid
• 10889981136574: Case Assembly
• 10889981136567: K-Wire Tube Assembly
• 10889981136550: Top Tray Coral MI System
• 10889981136543: Utility Caddy
• 10889981136536: Str & Contrd Conn Caddy
• 10889981136529: Lg Fixed Cross Conn Caddy
• 10889981136512: Fixed Cross Conn Caddy
• 10889981136505: Cross Connector Tray
• 10889981136345: CORAL FENESTRATED IMPLANTS INSTRUMENTS
• 10889981136338: CORAL FRICTION IMPLANTS INSTRUMENTS
• 10889981136321: CORAL CANNULATED IMPLANTS INSTRUMENTS
• 10889981136314: CORAL 1 IMPLANTS INSTRUMENTS
• 10889981135324: Screw Caddy - Aluminum
• 10889981135317: Inner Tray Bottom Level
• 10889981135300: Inner Tray Top Level
• 10889981129583: CORAL 1 DEFORMITY IMPLANTS 1
• 10889981123406: Instrument Case Lid
• 10889981123390: Degenerative Implant Base
• 10889981123383: Locking Cap Caddy Lid (2x)
• 10889981121440: Coral MIS Instrument Tray
• 10889981121181: CoCr Str. Rod 5.5 x 500
• 10889981121105: Integra Coral CrossBar Case
• 10889981120849: Fixed Screw 7.50mm x 20mm
• 10889981120832: Fixed Screw 6.50mm x 20mm
• 10889981120825: Fixed Screw 5.50mm x 20mm
• 10889981118860: CORAL® 1 DEGENERATIVE INSTRUMENTS 1
• 10889981117283: 8.5 Screw Caddy
• 10889981117276: 7.5 Screw Caddy
• 10889981117269: 6.5 Screw Caddy
• 10889981117252: 5.5 Screw Caddy
• 10889981117245: Locking Screw Caddy
• 10889981117238: Rod Caddy
• 10889981117221: Coral MIS Implant Tray
• 10889981117207: Pedicle Targeting Device
• 10889981117191: Screw Extension Re-Attachment Tool
• 10889981117184: Screw Extension Removal Tool
• 10889981117177: Compressor Handle