Reform Midline Cortical Screw System 59-DA-0102

GUDID 00815362026755

Ø4.75-Ø4.75 Parallel Domino, Open-Open, Narrow

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815362026755
• NIH Device Record Key: 4b8a8d7f-2f2a-4d57-b5d0-69a6aad1d45d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Midline Cortical Screw System
• Version Model Number: 59-DA-0102
• Catalog Number: 59-DA-0102
• 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	00815362026755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173130

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

[00815362026755]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-16
• Device Publish Date: 2019-05-08

On-Brand Devices [Reform Midline Cortical Screw System]

• 00815362025741: Ø7.5 x 80mm Midline Cortical Bone Screw, Cannulated
• 00815362025734: Ø7.5 x 70mm Midline Cortical Bone Screw, Cannulated
• 00815362025727: Ø7.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00815362025710: Ø7.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00815362025703: Ø7.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00815362025697: Ø7.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00815362025680: Ø7.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00815362025673: Ø7.5 x 35mm Midline Cortical Bone Screw, Cannulated
• 00815362025666: Ø7.5 x 30mm Midline Cortical Bone Screw, Cannulated
• 00815362025659: Ø6.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00815362025642: Ø6.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00815362025635: Ø6.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00815362025628: Ø6.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00815362025611: Ø6.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00815362025604: Ø6.5 x 35mm Midline Cortical Bone Screw, Cannulated
• 00815362025598: Ø6.5 x 30mm Midline Cortical Bone Screw, Cannulated
• 00815362025581: Ø6.5 x 25mm Midline Cortical Bone Screw, Cannulated
• 00815362025574: Ø5.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00815362025567: Ø5.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00815362025550: Ø5.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00815362025543: Ø5.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00815362025536: Ø5.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00815362025529: Ø5.5 x 35mm Midline Cortical Bone Screw, Cannulated
• 00815362025512: Ø5.5 x 30mm Midline Cortical Bone Screw, Cannulated
• 00815362025505: Ø5.5 x 25mm Midline Cortical Bone Screw, Cannulated
• 00815362025499: Ø5.0 x 60mm Midline Cortical Bone Screw, Cannulated
• 00815362025482: Ø5.0 x 55mm Midline Cortical Bone Screw, Cannulated
• 00815362025475: Ø5.0 x 50mm Midline Cortical Bone Screw, Cannulated
• 00815362025468: Ø5.0 x 45mm Midline Cortical Bone Screw, Cannulated
• 00815362025451: Ø5.0 x 40mm Midline Cortical Bone Screw, Cannulated
• 00815362025444: Ø5.0 x 35mm Midline Cortical Bone Screw, Cannulated
• 00815362025437: Ø5.0 x 30mm Midline Cortical Bone Screw, Cannulated
• 00815362025420: Ø5.0 x 25mm Midline Cortical Bone Screw, Cannulated
• 00815362025406: Ø4.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00815362025390: Ø4.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00815362025383: Ø4.5 x 35mm Midline Cortical Bone Screw, Cannulated
• 00815362025376: Ø4.5 x 30mm Midline Cortical Bone Screw, Cannulated
• 00815362025369: Ø4.5 x 25mm Midline Cortical Bone Screw, Cannulated
• 00815362025352: Ø10.5 x 90mm Midline Cortical Bone Screw, Cannulated
• 00815362025345: Ø10.5 x 80mm Midline Cortical Bone Screw, Cannulated
• 00815362025338: Ø10.5 x 70mm Midline Cortical Bone Screw, Cannulated
• 00815362025321: Ø10.5 x 60mm Midline Cortical Bone Screw, Cannulated
• 00815362025314: Ø10.5 x 55mm Midline Cortical Bone Screw, Cannulated
• 00815362025307: Ø10.5 x 50mm Midline Cortical Bone Screw, Cannulated
• 00815362025291: Ø10.5 x 45mm Midline Cortical Bone Screw, Cannulated
• 00815362025284: Ø10.5 x 40mm Midline Cortical Bone Screw, Cannulated
• 00815362025277: Ø10.5 x 120mm Midline Cortical Bone Screw, Cannulated
• 00815362025260: Ø10.5 x 110mm Midline Cortical Bone Screw, Cannulated
• 00815362025253: Ø10.5 x 100mm Midline Cortical Bone Screw, Cannulated
• 00815362025246: Ø4.75-Ø4.75 Axial Domino, Open-Closed