Malibu 16-5525

GUDID 10889981003654

MONOAXIAL SCREW, 5.5 x 25mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981003654
• NIH Device Record Key: 87fa6527-06e9-462e-ae78-6d178cd1c50b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malibu
• Version Model Number: 16-5525
• Catalog Number: 16-5525
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981003654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051663

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[10889981003654]

Moist Heat or Steam Sterilization

[10889981003654]

Moist Heat or Steam Sterilization

[10889981003654]

Moist Heat or Steam Sterilization

[10889981003654]

Moist Heat or Steam Sterilization

[10889981003654]

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]

• 10889981149482: Auxiliary Tray, Inner Pin Mat
• 10889981149475: Auxiliary Tray, Pin Mat
• 10889981149437: Auxiliary Tray, Lid
• 10889981149420: Auxiliary Tray, Inner
• 10889981149413: Auxiliary Tray, Dual Level
• 10889981149406: Auxiliary Tray, Single Level
• 10889981140250: Offset hook, 5.5 x 11mm, right
• 10889981140243: Angled hook, 5.5 x9.0mm, right
• 10889981140236: Angled hook, 5.5 x 9.0 mm, left
• 10889981140229: Angled hook 5.5 x 10mm, left
• 10889981134891: Offset hook, 5.5 x 11mm, left
• 10889981134884: Angled hook, 5.5 x10mm, right
• 10889981120320: Cannulated Uni-Planar Dlta Screw DIA 5.5 x 55mm
• 10889981119829: ESS SUBLAMINAR WIRE, 1 mm
• 10889981119652: CLOSED LATERAL CONNECTOR, 5.5/6.35 X 45MM
• 10889981119218: Persuader Set Instrument
• 10889981119126: Mallibu 2 Instrument
• 10889981083052: Variable Speed Ratcheting Handle, 1/4in. Square
• 10889981083045: Variable Speed Ratcheting Handle, AO
• 10889981082925: Locking Malibu Driver Free Sleeve
• 10889981082918: Locking Malibu Sliding Lock
• 10889981082901: Locking Malibu Driver Sleeve
• 10889981082895: Locking Malibu Driver Shaft
• 10889981082888: Top Down Persuader, Guide
• 10889981082871: Top Down Persuader
• 10889981082864: Tab Counter Torque
• 10889981082857: Threaded Awl 7.0mm (For 7.5mm Screw)
• 10889981082840: Threaded Awl 6.0mm (For 6.5mm Screw)
• 10889981082833: Threaded Awl 5.0mm (For 5.5mm Screw)
• 10889981082826: Luer Lock Bone Probe
• 10889981082802: Rotating Counter Torque
• 10889981082796: Bone Probe Stylet
• 10889981082789: Luer Lock Bone Probe Cap
• 10889981082772: Bone Probe, T-Handle
• 10889981082765: Pedicle Marker Pin
• 10889981082758: Pedicle Marker Pin
• 10889981082741: Pedicle Marker
• 10889981082734: Sacral Iliac Probe Guide
• 10889981082727: Sacral Iliac Probe
• 10889981082710: DLTA Screw Driver Shaft, Short
• 10889981082703: DLTA Screw Driver Shaft
• 10889981082697: Hook Pusher
• 10889981082680: Malibu Hook Holder
• 10889981082673: Pedicle Finder
• 10889981082666: Lamina Finder
• 10889981082635: AO Pedicle Marker, Regular
• 10889981082628: Modular Torque Indicating T-Handle, 1/4 QC
• 10889981082611: Ratchet Handle, Internal
• 10889981082604: Ratchet Handle
• 10889981082581: Ratchet T-Handle Extended