Foot Plate Locking Screw

GUDID B014FPS3528

EMINENT SPINE LLC

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

• Primary Device ID: B014FPS3528
• NIH Device Record Key: 9ee20442-a0b8-4e97-ad05-b888ef6ac21e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foot Plate Locking Screw
• Version Model Number: FPS3528
• 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	B014FPS3528 [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

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

Moist Heat or Steam Sterilization

[B014FPS3528]

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 Locking Screw ]

• B014FPS3540: FPS3540
• B014FPS3538: FPS3538
• B014FPS3536: FPS3536
• B014FPS3534: FPS3534
• B014FPS3532: FPS3532
• B014FPS3530: FPS3530
• B014FPS3528: FPS3528
• B014FPS3526: FPS3526
• B014FPS3524: FPS3524
• B014FPS3522: FPS3522
• B014FPS3520: FPS3520
• B014FPS3518: FPS3518
• B014FPS3516: FPS3516