Poly-Axial Reduction

GUDID B014IHP6045

EMINENT SPINE LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: B014IHP6045
• NIH Device Record Key: 6bcc7c10-35d1-4150-b8de-5bed6888b600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly-Axial Reduction
• Version Model Number: IHP6045
• 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	B014IHP6045 [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

[B014IHP6045]

Moist Heat or Steam Sterilization

[B014IHP6045]

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 [Poly-Axial Reduction]

• B014IHP7060: IHP7060
• B014IHP7055: IHP7055
• B014IHP7050: IHP7050
• B014IHP7045: IHP7045
• B014IHP7040: IHP7040
• B014IHP7035: IHP7035
• B014IHP7030: IHP7030
• B014IHP6060: IHP6060
• B014IHP6055: IHP6055
• B014IHP6050: IHP6050
• B014IHP6045: IHP6045
• B014IHP6040: IHP6040
• B014IHP6035: IHP6035
• B014IHP6030: IHP6030
• B014IHP5055: IHP5055
• B014IHP5050: IHP5050
• B014IHP5045: IHP5045
• B014IHP5040: IHP5040
• B014IHP5035: IHP5035
• B014IHP5030: IHP5030