Zuma-C 57-1309

GUDID 10889981076290

Zuma-C Implant, 13 x 12 x 9mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981076290
• NIH Device Record Key: dd4df6b8-d2e2-4f4e-82fc-706a6b1366c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zuma-C
• Version Model Number: 57-1309
• Catalog Number: 57-1309
• 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
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981076290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092521

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

Moist Heat or Steam Sterilization

[10889981076290]

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: 2015-12-22

On-Brand Devices [Zuma-C]

• 10889981120733: Zuma-C Universal Graft Packing Block
• 10889981120177: Zuma-C Implant, 17 x 13.5 x 12mm, Lordotic
• 10889981100414: Zuma-C Locking Cover Caddy
• 10889981100407: Zuma-C Implant Caddy, 17 x 12.5mm
• 10889981100391: Zuma-C Implant Caddy, 15 x 12mm
• 10889981100384: Zuma-C Implant Caddy, 13 x 12mm
• 10889981100377: Zuma-C Implant and Instrument Tray
• 10889981100360: Zuma-C 17mm Implant and Trial Tray
• 10889981100353: Zuma-C AIO Guide Tip Caddy
• 10889981100346: Zuma-C Locking Cap Caddy
• 10889981100339: Zuma-C Implant Caddy, 17 x 13.5mm
• 10889981100322: Zuma-C Implant Caddy, 15 x 13mm
• 10889981100315: Zuma-C Implant Caddy, 13 x 12mm
• 10889981100308: Zuma-C Implant and Instrument Tray
• 10889981100292: Zuma-C Rasp, 13x12x12mm, Lordotic
• 10889981100285: Zuma-C Rasp, 13x12x11mm, Lordotic
• 10889981100278: Zuma-C Rasp, 13x12x10mm, Lordotic
• 10889981100261: Zuma-C Rasp, 13x12x9mm, Lordotic
• 10889981100254: Zuma-C Rasp, 13x12x8mm, Lordotic
• 10889981100247: Zuma-C Rasp, 13x12x7mm, Lordotic
• 10889981100230: Zuma-C Rasp, 13x12x6mm, Lordotic
• 10889981100223: Graft Packing Block
• 10889981100216: Zuma-C Graft Tamp
• 10889981100193: Zuma-C Drill, 18mm
• 10889981100186: Zuma-C Drill, 16mm
• 10889981100179: Zuma-C Drill, 14mm
• 10889981100162: Zuma-C Drill, 12mm
• 10889981100155: Zuma-C Drill, 10mm
• 10889981100148: Freehand Drill Guide, Extended
• 10889981100131: Freehand Drill Guide
• 10889981100124: AIO Guide, 12 Deg
• 10889981100117: Plate Removal Tool
• 10889981100100: Screw Extracter, 2.5mm Hex
• 10889981100094: Locking Cover Extractor, 2.0mm Hex
• 10889981100087: Locking Cover Driver Shaft, Self Retaining
• 10889981100070: Torque Limiting Handle, 5 in-lbs
• 10889981100063: Distraction Pin Template
• 10889981100056: Zuma-C Awl
• 10889981100049: Zuma-C Implant Inserter
• 10889981100032: AIO Guide Tip, 12mm
• 10889981100025: AIO Guide Tip, 11mm
• 10889981100018: AIO Guide Tip, 10mm
• 10889981100001: AIO Guide Tip, 9mm
• 10889981099992: AIO Guide Tip, 8mm
• 10889981099985: AIO Guide Tip, 7mm
• 10889981099978: AIO Guide Tip, 6mm
• 10889981099961: AIO Guide Handle
• 10889981099954: Implant Tamp
• 10889981099947: Zuma-C Inserter Shaft, Extended
• 10889981099930: Zuma-C Inserter