Reform TI Pedicle Screw System 39-BK-1708

GUDID 00840019935821

Cannulated Implant Kit: Std + Outlier Ply + Red (Cr)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019935821
• NIH Device Record Key: 92a7f768-ebed-45a1-894a-56dede27939b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform TI Pedicle Screw System
• Version Model Number: 39-BK-1708
• Catalog Number: 39-BK-1708
• 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	00840019935821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121172

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

[00840019935821]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-11
• Device Publish Date: 2019-09-03

On-Brand Devices [Reform TI Pedicle Screw System]

• 00840019937252: Instrument Kit 1
• 00840019937245: Implant Kit: Std + Outlier Ply + Red (Cr)
• 00840019937238: Implant Kit: Std + Red (Cr)
• 00840019937221: Implant Kit: Std + Outlier Ply (Cr)
• 00840019937214: Implant Kit: Std: 5.5 - 7.5 Ply (Cr)
• 00840019937207: Implant Kit: Std + Outlier Ply + Red (Ti)
• 00840019937184: Implant Kit: Std + Outlier Ply (Ti)
• 00840019937177: Implant Kit: Std: 5.5 - 7.5 Ply (Ti)
• 00840019935883: Reduction Cannulated Polyaxial Screw Caddy
• 00840019935876: Outlier Cannulated Polyaxial Screw Caddy
• 00840019935869: ø7.5mm Cannulated Polyaxial Screw Caddy
• 00840019935852: ø6.5mm Cannulated Polyaxial Screw Caddy
• 00840019935845: ø5.5mm Cannulated Polyaxial Screw Caddy
• 00840019935838: Cannulated Instrument Kit 1
• 00840019935821: Cannulated Implant Kit: Std + Outlier Ply + Red (Cr)
• 00840019935814: Cannulated Implant Kit: Std + Red (Cr)
• 00840019935807: Cannulated Implant Kit: Std + Outlier Ply (Cr)
• 00840019935784: Cannulated Implant Kit: Std + Outlier Ply + Red (Ti)
• 00840019935777: Cannulated Implant Kit: Std + Red (Ti)
• 00840019935760: Cannulated Implant Kit: Std + Outlier Ply (Ti)
• 00840019935753: Cannulated Implant Kit: Std: 5.5 - 7.5 Ply (Ti)
• 00840019929226: Reduction Polyaxial Screw Caddy
• 00840019929219: Outlier Polyaxial Screw Caddy
• 00840019929202: ø7.5mm Polyaxial Screw Caddy
• 00840019929196: ø6.5mm Polyaxial Screw Caddy
• 00840019929189: ø5.5mm Polyaxial Screw Caddy
• 00840019929172: Polyaxial Driver
• 00840019929165: Retention Bone-Screw Driver
• 00840019903653: 9.5 x 90mm Reduction Polyaxial Screw
• 00840019903646: 9.5 x 80mm Reduction Polyaxial Screw
• 00840019903639: 9.5 x 70mm Reduction Polyaxial Screw
• 00840019903622: 9.5 x 60mm Reduction Polyaxial Screw
• 00840019903615: 9.5 x 55mm Reduction Polyaxial Screw
• 00840019903608: 9.5 x 50mm Reduction Polyaxial Screw
• 00840019903592: 9.5 x 45mm Reduction Polyaxial Screw
• 00840019903585: 9.5 x 40mm Reduction Polyaxial Screw
• 00840019903578: 9.5 x 120mm Reduction Polyaxial Screw
• 00840019903561: 9.5 x 110mm Reduction Polyaxial Screw
• 00840019903554: 9.5 x 100mm Reduction Polyaxial Screw
• 00840019903547: 8.5 x 90mm Reduction Polyaxial Screw
• 00840019903530: 8.5 x 80mm Reduction Polyaxial Screw
• 00840019903523: 8.5 x 70mm Reduction Polyaxial Screw
• 00840019903516: 8.5 x 60mm Reduction Polyaxial Screw
• 00840019903509: 8.5 x 55mm Reduction Polyaxial Screw
• 00840019903493: 8.5 x 50mm Reduction Polyaxial Screw
• 00840019903486: 8.5 x 45mm Reduction Polyaxial Screw
• 00840019903479: 8.5 x 40mm Reduction Polyaxial Screw
• 00840019903462: 8.5 x 35mm Reduction Polyaxial Screw
• 00840019903455: 8.5 x 120mm Reduction Polyaxial Screw
• 00840019903448: 8.5 x 110mm Reduction Polyaxial Screw