Reform® Ti Modular 39-BK-0522

GUDID 00840019935432

Modular Tower Tulip Caddy

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head Spinal bone screw head

• Primary Device ID: 00840019935432
• NIH Device Record Key: a2a2a3ba-4cb2-4644-990a-e641adaab02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform® Ti Modular
• Version Model Number: 39-BK-0522
• Catalog Number: 39-BK-0522
• 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: 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	00840019935432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150856

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

[00840019935432]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

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