Pre-Bent Rod

GUDID B014ICR15055

EMINENT SPINE LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B014ICR15055
• NIH Device Record Key: f0f555e3-19c0-426f-bffd-b035fedc849e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Bent Rod
• Version Model Number: ICR15055
• 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	B014ICR15055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100377

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[B014ICR15055]

Moist Heat or Steam Sterilization

[B014ICR15055]

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: 2017-02-21

On-Brand Devices [Pre-Bent Rod ]

• B014ICR9555: ICR9555
• B014ICR9055: ICR9055
• B014ICR8555: ICR8555
• B014ICR8055: ICR8055
• B014ICR7555: ICR7555
• B014ICR7055: ICR7055
• B014ICR6555: ICR6555
• B014ICR6055: ICR6055
• B014ICR5555: ICR5555
• B014ICR5055: ICR5055
• B014ICR4555: ICR4555
• B014ICR4055: ICR4055
• B014ICR15055: ICR15055
• B014ICR14055: ICR14055
• B014ICR13055: ICR13055
• B014ICR12055: ICR12055
• B014ICR11055: ICR11055
• B014ICR10055: ICR10055