Reform POCT 55-PB-3528-L

GUDID 00840019938716

Ø3.5 x 28mm Smooth Shank Screw - Constant Shank

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840019938716
• NIH Device Record Key: 42c137c4-e1aa-4be0-90e0-6946241c24a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform POCT
• Version Model Number: 55-PB-3528-L
• Catalog Number: 55-PB-3528-L
• 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	00840019938716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162300

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

[00840019938716]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-25
• Device Publish Date: 2020-06-17

On-Brand Devices [Reform POCT]

• 00840019938730: Ø3.5 x 32mm Smooth Shank Screw - Constant Shank
• 00840019938723: Ø3.5 x 30mm Smooth Shank Screw - Constant Shank
• 00840019938716: Ø3.5 x 28mm Smooth Shank Screw - Constant Shank
• 00840019938709: Ø3.5 x 26mm Smooth Shank Screw - Constant Shank
• 00840019938693: Ø3.5 x 22mm Smooth Shank Screw - Constant Shank