Palisade Pedicular Fixation System 670-4030

GUDID M7406704030

Fixed Curved Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod

• Primary Device ID: M7406704030
• NIH Device Record Key: 57fa7408-e69f-41da-9d62-04d2eb400bfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Palisade Pedicular Fixation System
• Version Model Number: 10-10-59-2
• Catalog Number: 670-4030
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter
• Device Size Text, specify: 0
• Length: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7406704030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153323

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

[M7406704030]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-22
• Device Publish Date: 2016-03-01

On-Brand Devices [Palisade Pedicular Fixation System]

• M7406704095: Palisade Fixed Curved Rod
• M7406700071: All In One Stylet, Short, Non-Sterile
• M7406700070: All In One Stylet, Long, Non-Sterile
• M7406710074: Revision Tower Reducer
• M7406710068: ASM, Locking Cap Ratchet Handle
• M7409000007: Ratcheting Axial Handle
• M7409000005: Torque Limiting Handle
• M7406710075: Counter Torque
• M7406710073: Alignment Tool
• M7406710072: Bone Rasp
• M7406710071: Rescue Tower
• M7406710070: Tower Adjustment Tool
• M7406710061: Rasp
• M7406710060: Impaction Cap
• M7406710059: Palisade Trajectory Portal
• M7406710058: Bevel Awl
• M7406710057: Trocar Awl
• M7406710053: Screw Height Adjuster
• M7406710052: Dilator One
• M7406710051: Rescue Sleeve
• M7406710050: Palm Handle Set Screw Placer
• M7406710049: Tulip Head Turner
• M7406710048: Rod Caliper
• M7406710040: Double Ended Set Screw Placer
• M7406710036: Tab Breaker
• M7406710035: Counter Torque
• M7406710030: Straight Rod Holder
• M7406710027: Compressor/Distractor Link
• M7406710025: Compressor/Distractor Tube
• M7406710024: Compressor/Distractor Handle
• M7406710016: Screwdriver
• M7406710008: Dilator Three
• M7406710007: Dilator Two
• M7406710005: Articulating Rod Holder Guide
• M7406710004: Ring Breaker
• M7406710002: Locking Set Screw Placer
• M7406420001: Rod Holder
• M7405300045: Rod Bender
• M7405300042: Ratcheting T-Handle
• M7406710055: Short 1/4 Drive Final Driver
• M7406710015: 7.5mm Tap
• M7406710014: 6.5mm Tap
• M7406710013: 5.5mm Tap
• M7406710012: 4.5mm Tap
• M7401001284: Stylet Wrench
• M7406710078: Extra Short Palisade Driver
• M7406700076: All In One Stylet, Extra-Short, Sterile
• M7406707590: Pedicle Screw
• M7406707580: Pedicle Screw
• M7406707570: Pedicle Screw