Zuma™ 55-3814

GUDID 10889981037314

Zuma Implant, 38mm x 26mm x 14mm, 8 Deg. Zuma™ is an implantable spinal device made from PEEK OPTIMA® and titanium with tantalum markers for radiogra

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981037314
• NIH Device Record Key: 3c8d8046-6820-43be-9248-e558144b111d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zuma™
• Version Model Number: 55-3814
• Catalog Number: 55-3814
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981037314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071726

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981037314]

Moist Heat or Steam Sterilization

[10889981037314]

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 [Zuma™]

• 10889981062576: Zuma-LP Caddy Implant
• 10889981062569: Zuma Implant
• 10889981062552: Zuma 38mm, 8 Deg Implants
• 10889981062545: Zuma 38mm, 12 Deg Implants
• 10889981062538: Zuma 26mm, 12 Deg Implants
• 10889981060732: Trial, 38mm x 26mm x 18mm, 12 Deg
• 10889981060725: Trial, 38mm x 26mm x 16mm, 12 Deg
• 10889981060718: Trial, 38mm x 26mm x 14mm, 12 Deg
• 10889981060701: Trial, 38mm x 26mm x 12mm, 12 Deg
• 10889981060695: Trial, 38mm x 26mm x 10mm, 12 Deg
• 10889981060688: Trial, 38mm x 26mm x 18mm, 8 Deg
• 10889981060671: Trial, 38mm x 26mm x 16mm, 8 Deg
• 10889981060664: Trial, 38mm x 26mm x 14mm, 8 Deg
• 10889981060657: Trial, 38mm x 26mm x 12mm, 8 Deg
• 10889981060640: Trial, 38mm x 26mm x 10mm, 8 Deg
• 10889981060633: Trial, 26mm x 24mm x 18mm, 12 Deg
• 10889981060626: Trial, 26mm x 24mm x 16mm, 12 Deg
• 10889981060619: Trial, 26mm x 24mm x 14mm, 12 Deg
• 10889981060602: Trial, 26mm x 24mm x 12mm, 12 Deg
• 10889981060596: Trial, 26mm x 24mm x 10mm, 12 Deg
• 10889981060589: Trial, 32mm x 25mm x 18mm, 12 Deg
• 10889981060572: Trial, 32mm x 25mm x 16mm, 12 Deg
• 10889981060565: Trial, 32mm x 25mm x 14mm, 12 Deg
• 10889981060558: Trial, 32mm x 25mm x 12mm, 12 Deg
• 10889981060541: Trial, 32mm x 25mm x 10mm, 12 Deg
• 10889981060534: Bone Screw, Ø6.0mm x 45mm
• 10889981060527: Bone Screw, Ø6.0mm x 40mm
• 10889981060510: Bone Screw, Ø6.0mm x 35mm
• 10889981060503: Bone Screw, Ø6.0mm x 30mm
• 10889981060497: Bone Screw, Ø6.0mm x 25mm
• 10889981060480: Bone Screw, Ø6.0mm x 20mm
• 10889981060473: LP Locking Cover, 18mm
• 10889981060466: LP Locking Cover, 16mm
• 10889981060459: LP Locking Cover, 14mm
• 10889981060442: LP Locking Cover, 12mm
• 10889981060435: LP Locking Cover, 10mm
• 10889981060428: Zuma Implant, 38mm x 26mm x 18mm, 12 Deg
• 10889981060411: Zuma Implant, 38mm x 26mm x 16mm, 12 Deg
• 10889981060404: Zuma Implant, 38mm x 26mm x 14mm, 12 Deg
• 10889981060398: Zuma Implant, 38mm x 26mm x 12mm, 12 Deg
• 10889981060381: Zuma Implant, 38mm x 26mm x 10mm, 12 Deg
• 10889981060374: Zuma-LP Implant, 32mm x 25mm x 18mm, 12 Deg
• 10889981060367: Zuma-LP Implant, 32mm x 25mm x 16mm, 12 Deg
• 10889981060350: Zuma-LP Implant, 32mm x 25mm x 14mm, 12 Deg
• 10889981060343: Zuma-LP Implant, 32mm x 25mm x 12mm, 12 Deg
• 10889981060336: Zuma-LP Implant, 32mm x 25mm x 10mm, 12 Deg
• 10889981060329: Zuma-LP Implant, 32mm x 25mm x 18mm, 8 Deg
• 10889981060312: Zuma-LP Implant, 32mm x 25mm x 16mm, 8 Deg
• 10889981060305: Zuma-LP Implant, 32mm x 25mm x 14mm, 8 Deg
• 10889981060299: Zuma-LP Implant, 32mm x 25mm x 12mm, 8 Deg