Oblique

GUDID B014O3011

EMINENT SPINE LLC

Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile

• Primary Device ID: B014O3011
• NIH Device Record Key: d17fc132-1656-4079-9b11-9c26ee787d6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oblique
• Version Model Number: O3011
• 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	B014O3011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090064

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B014O3011]

Moist Heat or Steam Sterilization

[B014O3011]

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: 2017-02-07

On-Brand Devices [Oblique ]

• B014O3315: O3315
• B014O3314: O3314
• B014O3313: O3313
• B014O3312: O3312
• B014O3311: O3311
• B014O3310: O3310
• B014O3309: O3309
• B014O3015: O3015
• B014O3014: O3014
• B014O3013: O3013
• B014O3012: O3012
• B014O3011: O3011
• B014O3010: O3010
• B014O3009: O3009
• B014O2715: O2715
• B014O2714: O2714
• B014O2713: O2713
• B014O2712: O2712
• B014O2711: O2711
• B014O2710: O2710
• B014O2709: O2709