UCR 10-1003

GUDID 10889981029340

ROD, 5.5 X 35MM

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981029340
• NIH Device Record Key: 69a60705-3925-4ae9-a095-f4a67f4cdcf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCR
• Version Model Number: 10-1003
• Catalog Number: 10-1003
• 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	10889981029340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043232

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[10889981029340]

Moist Heat or Steam Sterilization

[10889981029340]

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 [UCR]

• 10889981119492: UCR 2 Instrument
• 10889981082130: Rod Rotator, 5.5mm Dia
• 10889981082123: 5.5 Power Rod Gripper
• 10889981082109: Hook Inserter
• 10889981081072: Tap 6.0mm, Modular (for 6.5mm Screw)
• 10889981080402: COMPRESSOR
• 10889981080396: DISTRACTOR
• 10889981080372: Reduction THD Driver 5.5/6.75 mm
• 10889981080365: 4mm Hex, Large Axial Driver
• 10889981080358: 3mm Hex, Large Axial Driver
• 10889981080341: 3mm Driver, Small T-Handle
• 10889981080334: Static T-Handle, 4mm
• 10889981080327: Static T-Handle, 3mm
• 10889981080310: CrossBar Limiting Hex Driver
• 10889981080303: CROSSBAR HEX DRIVER
• 10889981080280: 5.0 mm Trial Rod Silicone Covered
• 10889981080273: 5.0 mm Trial Rod Silicone Covered
• 10889981080266: Deflection Beam Torque Wrench
• 10889981080259: COMBINATION WRENCH 3/16"
• 10889981080242: Tabletop Rod Cutter
• 10889981080235: LIMITING TORQUE T-HANDLE
• 10889981080228: Ratcheting T-Handle
• 10889981080211: RATCHETING DRIVER HANDLE
• 10889981080204: Rod Cutter
• 10889981080181: 20mm Jaw Set Distractor/Compressor (Set of Two)
• 10889981080174: Jaw Set 5.5mm - 6.35mm (Set of Two)
• 10889981080167: PARALLEL COMPRESSOR WITH INTERCHANGEABLE HNDLS
• 10889981080150: PARALLEL DISTRACTOR WITH INTERCHANGEABLE HNDLS
• 10889981080143: FRENCH ROD BENDER
• 10889981080129: Pedicle Sounder, Straight
• 10889981080105: Curved Probe
• 10889981080099: Straight Probe
• 10889981080082: Bone Awl
• 10889981080075: Solid Tap, 8.0mm
• 10889981080068: Tap, 8.0mm
• 10889981080051: Solid Tap, 6.75mm
• 10889981080044: Tap, 7.0mm
• 10889981080037: Solid Tap, 5.5mm
• 10889981080020: Tap, 5.5mm
• 10889981080013: UCR Instrument Tray
• 10889981080006: UCR Implant Tray
• 10889981079994: 4MM HEX SHAFT
• 10889981079987: 3mm Hex Shaft
• 10889981079956: Rod Fork
• 10889981079949: Rocker
• 10889981079932: Simple Tap Sleeve
• 10889981079925: X-RAY MARKER, LONG
• 10889981079918: X-RAY MARKER, SHORT
• 10889981079895: Hex Tip UCR Inserter, 8.0
• 10889981079888: Fixed Tip Inserter Sleeve, 8.0