Reform Ti Modular 39-BK-0527

GUDID 00840019967563

Instrument Kit 1, Closed Tulip Compatible

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019967563
• NIH Device Record Key: 7a6a9791-9864-49ba-8cd3-a47334a9e0e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Ti Modular
• Version Model Number: 39-BK-0527
• Catalog Number: 39-BK-0527
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019967563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200303

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

[00840019967563]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-26
• Device Publish Date: 2022-10-18

On-Brand Devices [Reform Ti Modular]

• 00840019934718: Ø9.5 x 110mm Polyaxial Screw, Cannulated
• 00840019934701: Ø9.5 x 100mm Polyaxial Screw, Cannulated
• 00840019934695: Ø9.5 x 90mm Polyaxial Screw, Cannulated
• 00840019934688: Ø9.5 x 80mm Polyaxial Screw, Cannulated
• 00840019934671: Ø9.5 x 70mm Polyaxial Screw, Cannulated
• 00840019934664: Ø9.5 x 60mm Polyaxial Screw, Cannulated
• 00840019934657: Ø9.5 x 55mm Polyaxial Screw, Cannulated
• 00840019934640: Ø9.5 x 50mm Polyaxial Screw, Cannulated
• 00840019934633: Ø9.5 x 45mm Polyaxial Screw, Cannulated
• 00840019934626: Ø9.5 x 40mm Polyaxial Screw, Cannulated
• 00840019934619: Ø8.5 x 120mm Polyaxial Screw, Cannulated
• 00840019934602: Ø8.5 x 110mm Polyaxial Screw, Cannulated
• 00840019934596: Ø8.5 x 100mm Polyaxial Screw, Cannulated
• 00840019934589: Ø8.5 x 90mm Polyaxial Screw, Cannulated
• 00840019934572: Ø8.5 x 80mm Polyaxial Screw, Cannulated
• 00840019934565: Ø8.5 x 70mm Polyaxial Screw, Cannulated
• 00840019934558: Ø8.5 x 60mm Polyaxial Screw, Cannulated
• 00840019934541: Ø8.5 x 55mm Polyaxial Screw, Cannulated
• 00840019934534: Ø8.5 x 50mm Polyaxial Screw, Cannulated
• 00840019934527: Ø8.5 x 45mm Polyaxial Screw, Cannulated
• 00840019934510: Ø8.5 x 40mm Polyaxial Screw, Cannulated
• 00840019934503: Ø8.5 x 35mm Polyaxial Screw, Cannulated
• 00840019934497: Ø7.5 x 80mm Polyaxial Screw, Cannulated
• 00840019934480: Ø7.5 x 70mm Polyaxial Screw, Cannulated
• 00840019934473: Ø7.5 x 60mm Polyaxial Screw, Cannulated
• 00840019934466: Ø7.5 x 55mm Polyaxial Screw, Cannulated
• 00840019934459: Ø7.5 x 50mm Polyaxial Screw, Cannulated
• 00840019934442: Ø7.5 x 45mm Polyaxial Screw, Cannulated
• 00840019934435: Ø7.5 x 40mm Polyaxial Screw, Cannulated
• 00840019934428: Ø7.5 x 35mm Polyaxial Screw, Cannulated
• 00840019934411: Ø7.5 x 30mm Polyaxial Screw, Cannulated
• 00840019934404: Ø6.5 x 60mm Polyaxial Screw, Cannulated
• 00840019934398: Ø6.5 x 55mm Polyaxial Screw, Cannulated
• 00840019934381: Ø6.5 x 50mm Polyaxial Screw, Cannulated
• 00840019934374: Ø6.5 x 45mm Polyaxial Screw, Cannulated
• 00840019934367: Ø6.5 x 40mm Polyaxial Screw, Cannulated
• 00840019934350: Ø6.5 x 35mm Polyaxial Screw, Cannulated
• 00840019934343: Ø6.5 x 30mm Polyaxial Screw, Cannulated
• 00840019934336: Ø6.5 x 25mm Polyaxial Screw, Cannulated
• 00840019934329: Ø5.5 x 60mm Polyaxial Screw, Cannulated
• 00840019934312: Ø5.5 x 55mm Polyaxial Screw, Cannulated
• 00840019934305: Ø5.5 x 50mm Polyaxial Screw, Cannulated
• 00840019934299: Ø5.5 x 45mm Polyaxial Screw, Cannulated
• 00840019934282: Ø5.5 x 40mm Polyaxial Screw, Cannulated
• 00840019934275: Ø5.5 x 35mm Polyaxial Screw, Cannulated
• 00840019934268: Ø5.5 x 30mm Polyaxial Screw, Cannulated
• 00840019934251: Ø5.5 x 25mm Polyaxial Screw, Cannulated
• 00840019934794: Ø10.5 x 80mm Polyaxial Screw, Cannulated
• 00840019934787: Ø10.5 x 70mm Polyaxial Screw, Cannulated
• 00840019934770: Ø10.5 x 60mm Polyaxial Screw, Cannulated