Reform Pedicle Screw System 39-BK-0305

GUDID 00840019937412

Implant Kit: Uni

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019937412
• NIH Device Record Key: 336ef1e9-f3fd-4164-94ea-916caaf9fab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Pedicle Screw System
• Version Model Number: 39-BK-0305
• Catalog Number: 39-BK-0305
• 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	00840019937412 [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

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

[00840019937412]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-12
• Device Publish Date: 2019-09-04

On-Brand Devices [Reform Pedicle Screw System]

• 00840019901826: ø5.5 x 600mm STRAIGHT ROD (Ti)
• 00840019900034: ø10.5 x 90 mm POLYAXIAL SCREW
• 00840019900027: ø10.5 x 80 mm POLYAXIAL SCREW
• 00840019900010: ø10.5 x 70 mm POLYAXIAL SCREW
• 00840019900003: ø10.5 x 60 mm POLYAXIAL SCREW
• 00815362028964: ø10.5 x 55 mm POLYAXIAL SCREW
• 00815362028957: ø10.5 x 50 mm POLYAXIAL SCREW
• 00815362028940: ø10.5 x 45 mm POLYAXIAL SCREW
• 00815362028933: ø10.5 x 40 mm POLYAXIAL SCREW
• 00815362028926: ø10.5 x 120 mm POLYAXIAL SCREW
• 00815362028919: ø10.5 x 110 mm POLYAXIAL SCREW
• 00815362028902: ø10.5 x 100 mm POLYAXIAL SCREW
• 00815362028896: Ø7.5mm x 50mm MIS Uniplanar Screw
• 00815362028889: Ø7.5mm x 45mm MIS Uniplanar Screw
• 00815362028872: Ø7.5mm x 40mm MIS Uniplanar Screw
• 00815362028865: Ø7.5mm x 35mm MIS Uniplanar Screw
• 00815362028858: Ø6.5mm x 50mm MIS Uniplanar Screw
• 00815362028841: Ø6.5mm x 45mm MIS Uniplanar Screw
• 00815362028834: Ø6.5mm x 40mm MIS Uniplanar Screw
• 00815362028827: Ø6.5mm x 35mm MIS Uniplanar Screw
• 00815362028810: Ø6.5mm x 30mm MIS Uniplanar Screw
• 00815362028803: Ø5.5mm x 50mm MIS Uniplanar Screw
• 00815362028797: Ø5.5mm x 45mm MIS Uniplanar Screw
• 00815362028780: Ø5.5mm x 40mm MIS Uniplanar Screw
• 00815362028773: Ø5.5mm x 35mm MIS Uniplanar Screw
• 00815362028766: Ø5.5mm x 30mm MIS Uniplanar Screw
• 00815362028759: Ø5.5mm x 25mm MIS Uniplanar Screw
• 00815362028742: Ø4.5mm x 45mm MIS Uniplanar Screw
• 00815362028735: Ø4.5mm x 40mm MIS Uniplanar Screw
• 00815362028728: Ø4.5mm x 35mm MIS Uniplanar Screw
• 00815362028711: Ø4.5mm x 30mm MIS Uniplanar Screw
• 00815362028704: Ø4.5mm x 25mm MIS Uniplanar Screw
• 00815362028698: Modular Polyaxial Reduction Tulip Assembly
• 00815362028681: Modular Polyaxial Tulip Assembly
• 00815362028674: Modular Polyaxial Bone Screw Ø9.5mm x 90mm
• 00815362028667: Modular Polyaxial Bone Screw Ø9.5mm x 80mm
• 00815362028650: Modular Polyaxial Bone Screw Ø9.5mm x 70mm
• 00815362028643: Modular Polyaxial Bone Screw Ø9.5mm x 60mm
• 00815362028636: Modular Polyaxial Bone Screw Ø9.5mm x 55mm
• 00815362028612: Modular Polyaxial Bone Screw Ø9.5mm x 45mm
• 00815362028605: Modular Polyaxial Bone Screw Ø9.5mm x 40mm
• 00815362028599: Modular Polyaxial Bone Screw Ø9.5mm x 120mm
• 00815362028582: Modular Polyaxial Bone Screw Ø9.5mm x 110mm
• 00815362028575: Modular Polyaxial Bone Screw Ø9.5mm x 100mm
• 00815362028568: Modular Polyaxial Bone Screw Ø8.5mm x 90mm
• 00815362028551: Modular Polyaxial Bone Screw Ø8.5mm x 80mm
• 00815362028544: Modular Polyaxial Bone Screw Ø8.5mm x 70mm
• 00815362028537: Modular Polyaxial Bone Screw Ø8.5mm x 60mm
• 00815362028520: Modular Polyaxial Bone Screw Ø8.5mm x 55mm
• 00815362028513: Modular Polyaxial Bone Screw Ø8.5mm x 50mm