Admiral AP1-300060

GUDID 10889981238469

Cervical Plate, 3 Level, 60mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981238469
• NIH Device Record Key: 73f23ad2-3166-4f44-bc39-f316b9a86617
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admiral
• Version Model Number: AP1-300060
• Catalog Number: AP1-300060
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981238469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202064

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

[10889981238469]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [Admiral]

• 10889981247683: Streamline Handle, Orange, Spin Top
• 10889981239831: 4.3mm Screw Caddy
• 10889981239824: 4.0mm Screw Caddy
• 10889981239817: Temporary Fixation Caddy
• 10889981239800: Trial Drill Guide Caddy
• 10889981239794: 5 Level Plate Caddy
• 10889981239787: 4 Level Plate Caddy
• 10889981239770: 3 Level Plate Caddy
• 10889981239763: 2 Level Plate Caddy
• 10889981239756: 1 Level Plate Caddy
• 10889981239749: ACP Misc Tray (4/5 Level Plate & Misc Tray)
• 10889981239732: ACP Fixation Tray (Prep & Insertion Tray)
• 10889981239725: ACP Implant Tray (Plate & Screw Tray)
• 10889981239718: ACP Tray Case
• 10889981239596: Cervical Plate, 3 Level, 78mm
• 10889981239589: Cervical Plate, 3 Level, 75mm
• 10889981239572: Cervical Plate, 3 Level, 72mm
• 10889981239565: Cervical Plate, 3 Level, 69mm
• 10889981239558: Cervical Plate, 3 Level, 66mm
• 10889981239541: Cervical Plate, 3 Level, 63mm
• 10889981239534: Cervical Plate, 3 Level, 57mm
• 10889981239527: Cervical Plate, 3 Level, 51mm
• 10889981239510: Cervical Plate, 3 Level, 45mm
• 10889981239503: Cervical Plate, 3 Level, 39mm
• 10889981239497: Plate Length Caliper, 52-80mm
• 10889981239473: Temporary Fixation Pin
• 10889981239459: Plate Length Caliper, 8-52mm
• 10889981239442: Plate Holder
• 10889981239435: Trial Drill Guide, 12mm
• 10889981239428: Trial Drill Guide, 11mm
• 10889981239411: Trial Drill Guide, 10mm
• 10889981239404: Trial Drill Guide, 9mm
• 10889981239398: Trial Drill Guide, 8mm
• 10889981239381: Trial Drill Guide, 7mm
• 10889981239374: Trial Drill Guide, 6mm
• 10889981239367: Trial Drill Guide, 5mm
• 10889981239350: Trial Drill Guide Inserter
• 10889981239343: Drill, 20mm
• 10889981239336: Drill, 18mm
• 10889981239329: Drill, 16mm
• 10889981239312: Drill, 14mm
• 10889981239305: Drill, 12mm
• 10889981239299: Drill, 10mm
• 10889981239282: Self Guiding Awl, 10mm, Variable
• 10889981239275: Awl, 10mm
• 10889981239268: Lateral DTS Guide, 15 Deg
• 10889981239251: Midline DTS Guide, 0, 15, 25 Deg
• 10889981239244: Drill Guide, Double Barrel, Variable
• 10889981239237: Lateral DTS Guide, 0 Deg
• 10889981239220: Drill Guide, Fixed