Anterior Cervical Plate 3-Level 66mm ACP366

GUDID 00840019904889

Anterior Cervical Plate 3-Level 66mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840019904889
• NIH Device Record Key: c54070c9-ff7a-4f7d-bbc5-e354d781bd70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterior Cervical Plate 3-Level 66mm
• Version Model Number: ACP366
• Catalog Number: ACP366
• 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	00840019904889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060025

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

[00840019904889]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-19
• Device Publish Date: 2019-04-11

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