SureLOK MIS 3L 63-CP-5525

GUDID 00840019905398

Pedicle Screw Ø5.5 x 25mm

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019905398
• NIH Device Record Key: bfa429d9-7488-46d2-a194-7998d4d318dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLOK MIS 3L
• Version Model Number: 63-CP-5525
• Catalog Number: 63-CP-5525
• 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: 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	00840019905398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141397

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

[00840019905398]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-16
• Device Publish Date: 2019-04-08

Devices Manufactured by PRECISION SPINE, INC.

• 00840019967969 - SureLOK MIS 3L: 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 160mm
• 00840019967976 - SureLOK MIS 3L: 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 170mm
• 00840019967983 - SureLOK MIS 3L: 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 180mm
• 00840019967990 - SureLOK MIS 3L: 2024-07-30 CL Percutaneous Straight Ti Rod, 5.5mm x 190mm
• 00840019938693 - Reform POCT: 2024-07-25 Ø3.5 x 22mm Smooth Shank Screw - Constant Shank
• 00840019938709 - Reform POCT: 2024-07-25 Ø3.5 x 26mm Smooth Shank Screw - Constant Shank
• 00840019938716 - Reform POCT: 2024-07-25 Ø3.5 x 28mm Smooth Shank Screw - Constant Shank
• 00840019938723 - Reform POCT: 2024-07-25 Ø3.5 x 30mm Smooth Shank Screw - Constant Shank