Reform Pedicle Screw System 39-AA-0101

GUDID 00815362027356

Axial Domino, Cl-Cl

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815362027356
• NIH Device Record Key: 53c8bd2b-4f65-466b-971a-c49decba8f3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Pedicle Screw System
• Version Model Number: 39-AA-0101
• Catalog Number: 39-AA-0101
• 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: true
• Lot Batch: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815362027356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130279

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

[00815362027356]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-22
• Device Publish Date: 2019-05-14

On-Brand Devices [ Reform Pedicle Screw System]

• 00815362027417: 66mm Cross Connector
• 00815362027400: 48mm Cross Connector
• 00815362027394: 40mm Cross Connector
• 00815362027387: 35mm Cross Connector
• 00815362027370: 32mm Cross Connector
• 00815362027363: 30mm Cross Connector
• 00815362027356: Axial Domino, Cl-Cl