Altus Spine Pedicle Screw System

GUDID 00843210132020

Rod Rocker

Altus Spine, LLC

Orthopaedic instrument surgical connector

• Primary Device ID: 00843210132020
• NIH Device Record Key: 98ceb52f-439f-4fcf-97ce-34fde385199f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altus Spine Pedicle Screw System
• Version Model Number: 905-0048
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843210132020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181281

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

[00843210132020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-09-25

On-Brand Devices [Altus Spine Pedicle Screw System]

• 00843210132907: Cannulated Tap, Single Lead
• 00843210132891: Cannulated Tap, Single Lead
• 00843210132884: Cannulated Tap, Single Lead
• 00843210132877: Cannulated Tap, Single Lead
• 00843210132860: Cannulated Tap, Single Lead
• 00843210132853: Pedicle Tap, Single Lead
• 00843210132846: Pedicle Tap, Single Lead
• 00843210132839: Pedicle Tap, Single Lead
• 00843210132822: Pedicle Tap, Single Lead
• 00843210132815: Pedicle Tap, Single Lead
• 00843210132808: Pedicle Tap, Single Lead
• 00843210132792: Rod Rocker Forcep
• 00843210132785: Polyaxial Screwdriver
• 00843210132778: Derotation Clamp
• 00843210132761: Derotation Clamp
• 00843210132754: Polyaxial Counter Torque
• 00843210132747: Head Persuader
• 00843210132730: Single Action Tower Reducer
• 00843210132723: Locking Cap Rod Reducer
• 00843210132716: Threaded Rod Reducer
• 00843210132709: Rod Rocker Fork
• 00843210132693: TA25 Locking Driver Closed Head Screw, Small Hudson
• 00843210132686: T25 Locking Driver Closed Head Screw
• 00843210132679: MIS TA25 Extension Locking Driver
• 00843210132662: MIS TA25 Extension Locking Driver, Square
• 00843210132655: MIS TA25 Extension Locking Driver
• 00843210132648: MIS TA25 Extension Locking Driver
• 00843210132631: MIS T25 Extension Locking Driver
• 00843210132624: Locking Driver, Mono-Axial
• 00843210132617: Locking Driver, Mono-Axial
• 00843210132600: Locking Driver, Mono-Axial
• 00843210132594: Locking Driver, Mono-Axial
• 00843210132587: Locking Driver, Flex Tab, Small Hudson
• 00843210132570: Locking Driver, Flex Tab
• 00843210132563: TA25 Reduction Locking Driver, Small Hudson
• 00843210132556: T25 Reduction Locking Driver
• 00843210132549: TA25 Locking Driver, Square
• 00843210132532: T25 Locking Driver, Square
• 00843210132525: T15 Locking Driver, Square
• 00843210132518: TA25 Locking Driver, Square
• 00843210132501: T25 Locking Driver, Square
• 00843210132495: TA25 Locking Driver
• 00843210132488: T25 Locking Driver
• 00843210132471: T15 Locking Driver
• 00843210132464: TA25 Locking Screw Driver, Tri-Lobe
• 00843210132457: TA25 Locking Driver
• 00843210132440: TA25 Locking Driver, Square
• 00843210132433: T25 Locking Driver, Square
• 00843210132426: TA25 Locking Driver
• 00843210132419: TA25 Locking Driver