Reform Ti Modular HA Pedicle Screw System 39-HM-9545

GUDID 00840019939768

9.5mm x 45mm Modular Bone Screw

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00840019939768
• NIH Device Record Key: b852a84e-1e2d-4cc5-9f61-6f7d56490cdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Ti Modular HA Pedicle Screw System
• Version Model Number: 39-HM-9545
• Catalog Number: 39-HM-9545
• 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: true
• 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	00840019939768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151422

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

[00840019939768]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [Reform Ti Modular HA Pedicle Screw System]

• 00840019939508: 6.5mm x 45mm Modular Bone Screw
• 00840019939492: 6.5mm x 40mm Modular Bone Screw
• 00840019939485: 6.5mm x 35mm Modular Bone Screw
• 00840019939478: 6.5mm x 30mm Modular Bone Screw
• 00840019939461: 6.5mm x 25mm Modular Bone Screw
• 00840019939454: 5.5mm x 60mm Modular Bone Screw
• 00840019939447: 5.5mm x 55mm Modular Bone Screw
• 00840019939430: 5.5mm x 50mm Modular Bone Screw
• 00840019939423: 5.5mm x 45mm Modular Bone Screw
• 00840019939416: 5.5mm x 40mm Modular Bone Screw
• 00840019939409: 5.5mm x 35mm Modular Bone Screw
• 00840019939393: 5.5mm x 30mm Modular Bone Screw
• 00840019939386: 5.5mm x 25mm Modular Bone Screw
• 00840019939379: 4.5mm x 45mm Modular Bone Screw
• 00840019939362: 4.5mm x 40mm Modular Bone Screw
• 00840019939355: 4.5mm x 35mm Modular Bone Screw
• 00840019939348: 4.5mm x 30mm Modular Bone Screw
• 00840019939331: 4.5mm x 25mm Modular Bone Screw
• 00840019939744: 8.5mm x 120mm Modular Bone Screw
• 00840019939737: 8.5mm x 110mm Modular Bone Screw
• 00840019939720: 8.5mm x 100mm Modular Bone Screw
• 00840019939713: 8.5mm x 90mm Modular Bone Screw
• 00840019939706: 8.5mm x 80mm Modular Bone Screw
• 00840019939690: 8.5mm x 70mm Modular Bone Screw
• 00840019939683: 8.5mm x 60mm Modular Bone Screw
• 00840019939676: 8.5mm x 55mm Modular Bone Screw
• 00840019939669: 8.5mm x 50mm Modular Bone Screw
• 00840019939652: 8.5mm x 45mm Modular Bone Screw
• 00840019939645: 8.5mm x 40mm Modular Bone Screw
• 00840019939638: 8.5mm x 35mm Modular Bone Screw
• 00840019939621: 7.5mm x 80mm Modular Bone Screw
• 00840019939614: 7.5mm x 70mm Modular Bone Screw
• 00840019939607: 7.5mm x 60mm Modular Bone Screw
• 00840019939591: 7.5mm x 55mm Modular Bone Screw
• 00840019939584: 7.5mm x 50mm Modular Bone Screw
• 00840019939577: 7.5mm x 45mm Modular Bone Screw
• 00840019939560: 7.5mm x 40mm Modular Bone Screw
• 00840019939553: 7.5mm x 35mm Modular Bone Screw
• 00840019939546: 7.5mm x 30mm Modular Bone Screw
• 00840019939539: 6.5mm x 60mm Modular Bone Screw
• 00840019939522: 6.5mm x 55mm Modular Bone Screw
• 00840019939515: 6.5mm x 50mm Modular Bone Screw
• 00840019939775: 9.5mm x 50mm Modular Bone Screw
• 00840019939768: 9.5mm x 45mm Modular Bone Screw
• 00840019939751: 9.5mm x 40mm Modular Bone Screw
• 00840019957991: Ø9.5 mm x 100mm Modular Bone Screw, Cannulated
• 00840019957984: Ø9.5 mm x 90mm Modular Bone Screw, Cannulated
• 00840019957847: Ø8.5 mm x 60mm Modular Bone Screw, Cannulated
• 00840019957830: Ø8.5 mm x 55mm Modular Bone Screw, Cannulated
• 00840019957823: Ø8.5 mm x 50mm Modular Bone Screw, Cannulated