Fang Plate

GUDID B014FP1224

EMINENT SPINE LLC

External spinal fixation system

• Primary Device ID: B014FP1224
• NIH Device Record Key: bf7dba24-e65a-4420-bb0a-3254890abba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fang Plate
• Version Model Number: FP1224
• 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	B014FP1224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090415

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B014FP1224]

Moist Heat or Steam Sterilization

[B014FP1224]

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 [Fang Plate]

• B014FP1227: FP1227
• B014FP1225: FP1225
• B014FP1224: FP1224
• B014FP1221: FP1221
• B014FP1220: FP1220