Foot Plate Screw

GUDID B014FPS2718

EMINENT SPINE LLC

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: B014FPS2718
• NIH Device Record Key: eec22c2b-bed2-4629-a58a-7c81730b4f0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foot Plate Screw
• Version Model Number: FPS2718
• Company DUNS: 022576742
• Company Name: EMINENT SPINE LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• 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
HIBCC	B014FPS2718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143365

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

[B014FPS2718]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-29
• Device Publish Date: 2017-02-08

On-Brand Devices [Foot Plate Screw]

• B014FPS2740: FPS2740
• B014FPS2738: FPS2738
• B014FPS2736: FPS2736
• B014FPS2734: FPS2734
• B014FPS2732: FPS2732
• B014FPS2730: FPS2730
• B014FPS2728: FPS2728
• B014FPS2726: FPS2726
• B014FPS2724: FPS2724
• B014FPS2722: FPS2722
• B014FPS2720: FPS2720
• B014FPS2718: FPS2718
• B014FPS2716: FPS2716
• B014FPS2714: FPS2714
• B014FPS2712: FPS2712
• B014FPS2710: FPS2710