Reform® Ti Modular 39-BK-0522

GUDID 00840019935432

Modular Tower Tulip Caddy

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019935432
• NIH Device Record Key: a2a2a3ba-4cb2-4644-990a-e641adaab02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform® Ti Modular
• Version Model Number: 39-BK-0522
• Catalog Number: 39-BK-0522
• 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	00840019935432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150856

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00840019935432]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

Devices Manufactured by PRECISION SPINE, INC.

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• 00840019930949 - Reform POCT System: 2024-04-17 Ø3.5 x 36mm Polyaxial Screw - M/L Bias
• 00840019930956 - Reform POCT System: 2024-04-17 Ø3.5 x 38mm Polyaxial Screw - M/L Bias
• 00840019930963 - Reform POCT System: 2024-04-17 Ø4.0 x 32mm Polyaxial Screw - M/L Bias
• 00840019930970 - Reform POCT System: 2024-04-17 Ø4.0 x 34mm Polyaxial Screw - M/L Bias
• 00840019930987 - Reform POCT System: 2024-04-17 Ø4.0 x 36mm Polyaxial Screw - M/L Bias
• 00840019930994 - Reform POCT System: 2024-04-17 Ø4.0 x 38mm Polyaxial Screw - M/L Bias