Reform MC Screw System 59-BK-4000

GUDID 00840019930789

Retractor Kit

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019930789
• NIH Device Record Key: 794ad6cd-ccbe-4da6-b032-ec1af35bf3d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform MC Screw System
• Version Model Number: 59-BK-4000
• Catalog Number: 59-BK-4000
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019930789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173130

FDA Product Code

• HXL: Mallet

Sterilization

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

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

[00840019930789]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-08
• Device Publish Date: 2024-02-29

On-Brand Devices [Reform MC Screw System]

• 00840019927994: Modular Screw Driver
• 00840019927987: Adjustment Screw Driver
• 00840019927970: Ø6.5mm Power Bone Drill
• 00840019927963: Ø5.5mm Power Bone Drill
• 00840019927956: Ø5.0mm Power Bone Drill
• 00840019927932: Ø6.5mm Cortical Drill
• 00840019927895: Tulip Manipulator
• 00840019927888: Drill Guide, Adjustable
• 00840019927871: Outlier Drill Guide, Adjustable
• 00840019927864: Bone Awl
• 00840019927857: Blade Depth Indicator
• 00840019927840: Ball Tip Sounder, Straight
• 00840019927833: Midline Blade Inserter
• 00840019927826: Midline Retractor Assembly
• 00840019927819: Puppet Leg Distractor
• 00840019927802: Bone Awl
• 00840019927796: T-Handle Reducer
• 00840019927789: Trajectory Tube Assembly
• 00840019927772: Reduction Tower
• 00840019927765: Reduction Gun
• 00840019927758: Rod Holder
• 00840019927741: Rod Pusher
• 00840019927734: Counter-Torque
• 00840019927710: In Situ Bender, Left
• 00840019927703: Parallel Distractor
• 00840019927680: Flexible Rod - 250mm
• 00840019927666: Flexible Rod Template -Ø3.5mm
• 00840019927642: Double Level Blade, Right, 110mm
• 00840019927635: Double Level Blade, Right, 100mm
• 00840019927628: Double Level Blade, Right, 90mm
• 00840019927604: Double Level Blade, Right, 70mm
• 00840019927598: Double Level Blade, Right, 60mm
• 00840019927581: Double Level Blade, Right, 50mm
• 00840019927574: Double Level Blade, Right, 40mm
• 00840019927567: Single Level Blade, Right, 110mm
• 00840019927543: Single Level Blade, Right, 90mm
• 00840019927536: Single Level Blade, Right, 80mm
• 00840019927512: Single Level Blade, Right, 60mm
• 00840019927505: Single Level Blade, Right, 50mm
• 00840019927499: Single Level Blade, Right, 40mm
• 00840019927482: Modular Screw Driver
• 00840019927475: Ø9.5mm Cannulated Screw Tap
• 00840019927468: Ø8.5mm Cannulated Screw Tap
• 00840019927451: Ø7.5mm Cannulated Screw Tap
• 00840019927413: Ø4.5mm Cannulated Screw Tap
• 00840019927406: Double Level Blade, Left, 110mm
• 00840019927390: Double Level Blade, Left, 100mm
• 00840019927383: Double Level Blade, Left, 90mm
• 00840019927376: Double Level Blade, Left, 80mm
• 00840019927369: Double Level Blade, Left, 70mm