Zuma 55-3920

GUDID 10889981076252

Zuma Implant, 38mm x 26mm x 20mm, 12 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981076252
• NIH Device Record Key: e47abb3c-f0f0-4053-b418-c4769ff6e25e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zuma
• Version Model Number: 55-3920
• Catalog Number: 55-3920
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981076252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082926

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981076252]

Moist Heat or Steam Sterilization

[10889981076252]

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]

• 10889981120627: Graft Packing Block, 38mm x 26mm
• 10889981120610: Slap Hammer Connector
• 10889981120160: Zuma Implant, 38mm x 26mm x 22mm, 12 Deg
• 10889981120153: Zuma Implant, 26mm x 24mm x 22mm, 12 deg
• 10889981119584: Zuma 2 Instrument
• 10889981097592: 3/16" Square Quick Connect Handle
• 10889981097578: Wedge Distractor, 16mm
• 10889981097561: Wedge Distractor, 14mm
• 10889981097554: Wedge Distractor, 12mm
• 10889981097547: Wedge Distractor, 10mm
• 10889981097530: Wedge Distractor, 8mm
• 10889981097523: Narrow Head Inserter
• 10889981097493: Modular Bullet Paddle Distractor 18mm
• 10889981097486: Modular Bullet Paddle Distractor 17mm
• 10889981097479: Modular Bullet Paddle Distractor 16mm
• 10889981097462: Modular Bullet Paddle Distractor 15mm
• 10889981097455: Modular Bullet Paddle Distractor 14mm
• 10889981097448: Modular Bullet Paddle Distractor 13mm
• 10889981097431: Modular Bullet Paddle Distractor 12mm
• 10889981097424: Modular Bullet Paddle Distractor 10mm
• 10889981097417: Modular Bullet Paddle Distractor 8mm
• 10889981097394: Mask Handle
• 10889981097387: Fixed Mask AIO Guide
• 10889981097370: Variable Mask AIO Guide
• 10889981097349: Mask, 18mm
• 10889981097332: Mask, 16mm
• 10889981097325: Mask, 14mm
• 10889981097318: Mask, 12mm
• 10889981097301: Mask, 10mm
• 10889981097295: Slotted Mallet
• 10889981097264: Paddle Distractor, 18mm
• 10889981097257: Paddle Distractor, 17mm
• 10889981097240: Paddle Distractor, 16mm
• 10889981097233: Paddle Distractor, 15mm
• 10889981097226: Paddle Distractor, 14mm
• 10889981097219: Paddle Distractor, 13mm
• 10889981097202: Paddle Distractor, 12mm
• 10889981097196: Paddle Distractor, 10mm
• 10889981097189: Paddle Distractor, 8mm
• 10889981097172: EZ Out, 3mm Hex
• 10889981097165: Modular Handle, 1/4 In. Square
• 10889981097158: Drill Handle, AO Connect
• 10889981097141: Zuma-LP Implant/Trial Caddy, 32mm x 25mm, 12 Deg
• 10889981097134: Zuma Implant/Trial Caddy 38mm x 26mm, 12 Deg
• 10889981097127: Zuma Implant/Trial Caddy 38mm x 26mm, 8 Deg
• 10889981097110: Zuma 6.0mm Bone Screw Caddy
• 10889981097103: Ratchet Handle
• 10889981097097: Zuma Implant/Trial Caddy 32mm x 25mm, 12 Deg
• 10889981097080: Zuma Implant/Trial Caddy 26mm x 24mm, 12 Deg
• 10889981097073: Zuma Instrument Tray