Malibu™ 15-1350

GUDID 10889981030124

PRECONTOURED ESS ROD, 5.5 x 350 mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981030124
• NIH Device Record Key: e31b9cdf-8a77-418e-8f37-312fd0251ea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malibu™
• Version Model Number: 15-1350
• Catalog Number: 15-1350
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981030124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072605

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

Moist Heat or Steam Sterilization

[10889981030124]

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 [Malibu™]

• 10889981030834: PRECONTOURED ESS PLUS ROD, 5.5 x 600 mm
• 10889981030827: PRECONTOURED ESS PLUS ROD, 5.5 x 500 mm
• 10889981030810: PRECONTOURED ESS PLUS ROD, 5.5 x 400 mm
• 10889981030803: PRECONTOURED ESS PLUS ROD, 5.5 x 300 mm
• 10889981030797: ESS PLUS ROD, 5.5 x 450 mm
• 10889981030162: MALIBU MONO/HOOK CAP, 5.5/6.35
• 10889981030155: PRECONTOURED ESS ROD, 5.5 x 600 mm
• 10889981030148: PRECONTOURED ESS ROD, 5.5 x 500 mm
• 10889981030131: PRECONTOURED ESS ROD, 5.5 x 400 mm
• 10889981030124: PRECONTOURED ESS ROD, 5.5 x 350 mm
• 10889981030117: PRECONTOURED ESS ROD, 5.5 x 300 mm
• 10889981030100: PRECONTOURED ESS ROD, 5.5 x 90 mm
• 10889981030094: PRECONTOURED ESS ROD, 5.5 x 80 mm
• 10889981030087: ESS ROD, 5.5 x 600 mm
• 10889981030070: ESS ROD, 5.5 x 450 mm
• 10889981030063: ESS ROD, 5.5 x 250 mm
• 10889981030056: ESS ROD, 5.5 x 100 mm
• 10889981030049: PRECONTOURED ROD, 5.5 x 75mm
• 10889981030032: PRECONTOURED ROD, 5.5 x 65mm
• 10889981030025: PRECONTOURED ROD, 5.5 x 55mm
• 10889981030018: PRECONTOURED ROD, 5.5 x 45mm
• 10889981030001: ROD CONNECTOR, 5.5 x 5.5
• 10889981029999: PRECONTOURED ROD, 5.5 x 80mm
• 10889981029982: PRECONTOURED ROD, 5.5 x 70mm
• 10889981029975: PRECONTOURED ROD, 5.5 x 60mm
• 10889981029968: PRECONTOURED ROD, 5.5 x 50mm
• 10889981029951: PRECONTOURED ROD, 5.5 x 40mm
• 10889981029944: PRECONTOURED ROD, 5.5 x 35mm
• 10889981029937: PRECONTOURED ROD, 5.5 x 30mm
• 10889981029920: SCREW SPACER 7.0-7.5mmDIA X 5.0mm
• 10889981029913: SCREW SPACER 6.0-6.5mmDIA X 2.5mm
• 10889981029906: SCREW SPACER 4.5-8.5MM X 5.0MM
• 10889981029890: CLOSED LATERAL CONNECTOR, 6.35 X 60MM
• 10889981029883: ESS SUBLAMINAR WIRE, 1.2 mm
• 10889981029876: PRECONTOURED TI ROD, 5.5 X 500mm
• 10889981029869: PRECONTOURED TI ROD, 5.5 X 400mm
• 10889981029852: PRECONTOURED TI ROD, 5.5 X 300mm
• 10889981029845: CLOSED LATERAL CONNECTOR, 6.35 X 45MM
• 10889981029838: CLOSED LATERAL CONNECTOR, 6.35 X 30MM
• 10889981029821: CLOSED LATERAL CONNECTOR, 5.5/6.35 X 60MM
• 10889981029814: CLOSED LATERAL CONNECTOR, 5.5 X 60MM
• 10889981029807: CLOSED LATERAL CONNECTOR, 5.5 X 45MM
• 10889981029791: CLOSED LATERAL CONNECTOR, 5.5 X 30MM
• 10889981029784: PRECONTOURED ROD, 5.5 x 130mm
• 10889981029777: PRECONTOURED ROD, 5.5 x 120mm
• 10889981029760: PRECONTOURED ROD, 5.5 x 110mm
• 10889981029753: PRECONTOURED ROD, 5.5 x 100mm
• 10889981029746: PRECONTOURED ROD, 5.5 x 90mm
• 10889981029739: CLOSED LATERAL CONNECTOR, 5.5/6.35 X 30MM
• 10889981029722: ROD CONNECTOR, 5.5/6.35