Valencia Pedicle Screw System

GUDID 00843210112022

6.5mm x 40mm Monoaxial Self Tapping Pedicle Screw

Altus Spine, LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00843210112022
• NIH Device Record Key: cd3fd71e-a8d9-49e3-9360-e23e04c31bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valencia Pedicle Screw System
• Version Model Number: 925-6540
• Company DUNS: 078331322
• Company Name: Altus Spine, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com
• Phone: +1(610)-355-4156
• Email: Info@altus-spine.com

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210112022 [Primary]
HIBCC	B41792565401 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033352

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

Moist Heat or Steam Sterilization

[00843210112022]

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: 2017-12-29

On-Brand Devices [Valencia Pedicle Screw System]

• 00843210134765: X connector Module Lid
• 00843210134758: X connector Module Base
• 00843210134741: 8.5mm Pedicle Tap,Cannulated
• 00843210134734: 7.5mm Pedicle Tap, Cannulated
• 00843210134727: 6.5mm Pedicle Tap, Cannulated
• 00843210134710: 5.5mm Pedicle Tap, Cannulated
• 00843210134703: Cannulated Probe
• 00843210134697: Valencia Auxillary Case Lid-Valencia
• 00843210134680: Rod Module Lid, Valencia II
• 00843210134673: Rod Module, Valencia II
• 00843210134666: Valencia Screw Module Standard Pedicle Screw
• 00843210134659: Auxiliary Case
• 00843210134642: Valencia Sterilization Case 2
• 00843210134635: Valencia Sterilization Case 1
• 00843210134628: T-25 Inserter, Hudson
• 00843210134611: T-25 Drive Shaft, Long
• 00843210134604: Counter Torque, Long
• 00843210134598: MIS Tab Removal, Cannulated
• 00843210134581: Reduction Collar
• 00843210134574: T-25 Tapered Inserter
• 00843210134567: T-25 Removable Tip, Tapered
• 00843210134550: T-25 Final Drive Shaft
• 00843210134543: Rod Pusher
• 00843210134536: Straight Ratcheting Handle
• 00843210134529: Large T-Handle, Ratchet
• 00843210134512: Curved Probe, Duck Bill
• 00843210134505: Straight Probe, Duck Bill
• 00843210134499: Sound Curved
• 00843210134482: Sound
• 00843210134475: Bone Probe Lenke-Style Curve
• 00843210134468: Bone Probe Lenke-Style Strgt
• 00843210134451: PSS: Rod Template
• 00843210134406: Pedicle Marker, Left
• 00843210134390: Pedicle Marker, Right
• 00843210134383: PSS: Counter Torque Instrument
• 00843210134376: PSS: Rod Holder
• 00843210134369: PSS: Screwdriver
• 00843210134352: PARALLEL DISTRACTOR
• 00843210134345: PARALLEL COMPRESSOR
• 00843210134338: PSS: Distractor
• 00843210134321: PSS: Compressor
• 00843210134277: PSS: Rod Bender
• 00843210134260: PSS: T-Handle Ratchet
• 00843210134222: PSS: Awl
• 00843210133416: T-25 Inserter Shaft
• 00843210133171: Sterilization Case Lid
• 00843210121789: 4.5mm x 25mm Monoaxial Self Tapping Pedicle Screw
• 00843210121772: 480mm Guide Wire, Round Tip, Nitinol
• 00843210121765: 480mm Guide Wire, Round Tip, Nitinol
• 00843210121758: 8.5mm x 100mm Cannulated Extension Pedicle Screw