Reform TI Pedicle Screw System 39-SB-4540

GUDID 00840019931816

Modular Bone Screw, 4.5mm x 40mm, Magenta

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019931816
• NIH Device Record Key: 10c40b1a-a26f-4856-86d9-8114bf86ae05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform TI Pedicle Screw System
• Version Model Number: 39-SB-4540
• Catalog Number: 39-SB-4540
• 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	00840019931816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150856

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

[00840019931816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-10
• Device Publish Date: 2019-05-31

On-Brand Devices [Reform TI Pedicle Screw System]

• 00840019932301: Modular Bone Screw, 9.5mm x 120mm, Natural
• 00840019932295: Modular Bone Screw, 9.5mm x 110mm, Natural
• 00840019932288: Modular Bone Screw, 9.5mm x 100mm, Natural
• 00840019932271: Modular Bone Screw, 9.5mm x 90mm, Natural
• 00840019932264: Modular Bone Screw, 9.5mm x 80mm, Natural
• 00840019932257: Modular Bone Screw, 9.5mm x 70mm, Natural
• 00840019932240: Modular Bone Screw, 9.5mm x 60mm, Natural
• 00840019932233: Modular Bone Screw, 9.5mm x 55mm, Natural
• 00840019932226: Modular Bone Screw, 9.5mm x 50mm, Natural
• 00840019932219: Modular Bone Screw, 9.5mm x 45mm, Natural
• 00840019932202: Modular Bone Screw, 9.5mm x 40mm, Natural
• 00840019932189: Modular Bone Screw, 8.5mm x 110mm, Bronze
• 00840019932172: Modular Bone Screw, 8.5mm x 100mm, Bronze
• 00840019932165: Modular Bone Screw, 8.5mm x 90mm, Bronze
• 00840019932158: Modular Bone Screw, 8.5mm x 80mm, Bronze
• 00840019932141: Modular Bone Screw, 8.5mm x 70mm, Bronze
• 00840019932134: Modular Bone Screw, 8.5mm x 60mm, Bronze
• 00840019932110: Modular Bone Screw, 8.5mm x 50mm, Bronze
• 00840019932103: Modular Bone Screw, 8.5mm x 45mm, Bronze
• 00840019932097: Modular Bone Screw, 8.5mm x 40mm, Bronze
• 00840019932417: Modular Bone Screw, 10.5mm x 120mm, Purple
• 00840019932400: Modular Bone Screw, 10.5mm x 110mm, Purple
• 00840019932394: Modular Bone Screw,10.5mm x 100mm, Purple
• 00840019932387: Modular Bone Screw, 10.5mm x 90mm, Purple
• 00840019932370: Modular Bone Screw, 10.5mm x 80mm, Purple
• 00840019932363: Modular Bone Screw, 10.5mm x 70mm, Purple
• 00840019932356: Modular Bone Screw, 10.5mm x 60mm, Purple
• 00840019932349: Modular Bone Screw, 10.5mm x 55mm, Purple
• 00840019932332: Modular Bone Screw, 10.5mm x 50mm, Purple
• 00840019932325: Modular Bone Screw, 10.5mm x 45mm, Purple
• 00840019932318: Modular Bone Screw, 10.5mm x 40mm, Purple
• 00840019932080: Modular Bone Screw, 8.5mm x 35mm, Bronze
• 00840019932073: Modular Bone Screw, 7.5mm x 80mm, Dark Blue
• 00840019932066: Modular Bone Screw, 7.5mm x 70mm, Dark Blue
• 00840019932059: Modular Bone Screw, 7.5mm x 60mm, Dark Blue
• 00840019932042: Modular Bone Screw, 7.5mm x 55mm, Dark Blue
• 00840019932035: Modular Bone Screw, 7.5mm x 50mm, Dark Blue
• 00840019932028: Modular Bone Screw, 7.5mm x 45mm, Dark Blue
• 00840019932011: Modular Bone Screw, 7.5mm x 40mm, Dark Blue
• 00840019931991: Modular Bone Screw, 7.5mm x 30mm, Dark Blue
• 00840019931984: Modular Bone Screw, 6.5mm x 60mm, Green
• 00840019931977: Modular Bone Screw, 6.5mm x 55mm, Green
• 00840019931960: Modular Bone Screw, 6.5mm x 50mm, Green
• 00840019931953: Modular Bone Screw, 6.5mm x 45mm, Green
• 00840019931946: Modular Bone Screw, 6.5mm x 40mm, Green
• 00840019931939: Modular Bone Screw, 6.5mm x 35mm, Green
• 00840019931922: Modular Bone Screw, 6.5mm x 30mm, Green
• 00840019931915: Modular Bone Screw, 6.5mm x 25mm, Green
• 00840019931908: Modular Bone Screw, 5.5mm x 60mm, Gold
• 00840019931892: Modular Bone Screw, 5.5mm x 55mm, Gold