Zuma-L™ 56-8030

GUDID 10889981059750

Bone Screw, 6.5 x 30mm

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

• Primary Device ID: 10889981059750
• NIH Device Record Key: 411b3bc8-07a8-488a-8dc0-120a4b1d3430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zuma-L™
• Version Model Number: 56-8030
• Catalog Number: 56-8030
• 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

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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981059750 [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

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

Moist Heat or Steam Sterilization

[10889981059750]

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-L™]

• 10889981062521: Zuma-L 3 Implant
• 10889981062514: Zuma-L 2 Implant
• 10889981060152: Height Trial, 45mm x 18mm, 8° , L4-L5
• 10889981060145: Height Trial, 45mm x 16mm, 8° , L4-L5
• 10889981060138: Height Trial, 45mm x 14mm, 8° , L4-L5
• 10889981060121: Height Trial, 45mm x 12mm, 8° , L4-L5
• 10889981060114: Height Trial, 45mm x 10mm, 8° , L4-L5
• 10889981060107: Height Trial, 45mm x 8mm, 8° , L4-L5
• 10889981060091: Angled Starter Trial
• 10889981060084: Zuma-L Depth Trial, L4-L5
• 10889981060077: Height Trial, 45mm x 18mm, 0 ° , L4-L5
• 10889981060060: Height Trial, 45mm x 16mm, 0 ° , L4-L5
• 10889981060053: Height Trial, 45mm x 14mm, 0 ° , L4-L5
• 10889981060046: Height Trial, 45mm x 12mm, 0 ° , L4-L5
• 10889981060039: Height Trial, 45mm x 10mm, 0 ° , L4-L5
• 10889981060022: Height Trial, 45mm x 8mm, 0 ° , L4-L5
• 10889981060015: Height Trial, 45mm x 18mm, 0 Deg
• 10889981060008: Height Trial, 45mm x 16mm, 0 Deg
• 10889981059996: Height Trial, 45mm x 14mm, 0 Deg
• 10889981059989: Height Trial, 45mm x 12mm, 0 Deg
• 10889981059972: Height Trial, 45mm x 10mm, 0 Deg
• 10889981059965: Height Trial, 45mm x 08mm, 0 Deg
• 10889981059958: Height Trial, 45 mm x 18 mm, 8°
• 10889981059941: Height Trial, 45 mm x 16 mm, 8°
• 10889981059934: Height Trial, 45 mm x 14 mm, 8°
• 10889981059927: Height Trial, 45 mm x 12 mm, 8°
• 10889981059910: Height Trial, 45 mm x 10 mm, 8°
• 10889981059903: Height Trial, 45 mm x 08 mm, 8°
• 10889981059897: Lateral Depth Trial, Small Hudson
• 10889981059880: Zuma-L Locking Cover, 18mm
• 10889981059873: Zuma-L Locking Cover, 16mm
• 10889981059866: Zuma-L Locking Cover, 14mm
• 10889981059859: Zuma-L Locking Cover, 12mm
• 10889981059842: Zuma-L Locking Cover, 10mm
• 10889981059835: Zuma-L Locking Cover, 8mm
• 10889981059828: Bone Screw, 6.5 x 65mm
• 10889981059811: Bone Screw, 6.5 x 60mm
• 10889981059804: Bone Screw, 6.5 x 55mm
• 10889981059798: Bone Screw, 6.5 x 50mm
• 10889981059781: Bone Screw, 6.5 x 45mm
• 10889981059774: Bone Screw, 6.5 x 40mm
• 10889981059767: Bone Screw, 6.5 x 35mm
• 10889981059750: Bone Screw, 6.5 x 30mm
• 10889981059743: Bone Screw, 6.5 x 25mm
• 10889981059736: Bone Screw, 5.5 x 65mm
• 10889981059729: Bone Screw, 5.5 x 60mm
• 10889981059712: Bone Screw, 5.5 x 55mm
• 10889981059705: Bone Screw, 5.5 x 50mm
• 10889981059699: Bone Screw, 5.5 x 45mm
• 10889981059682: Bone Screw, 5.5 x 40mm