Osteotomy Plate

GUDID B014FOR21

EMINENT SPINE LLC

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

• Primary Device ID: B014FOR21
• NIH Device Record Key: c07b8886-975a-4f60-a94f-96283da744c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotomy Plate
• Version Model Number: FOR21
• 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	B014FOR21 [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

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

Moist Heat or Steam Sterilization

[B014FOR21]

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: 2017-02-13

On-Brand Devices [Osteotomy Plate]

• B014FOR45: FOR45
• B014FOR39: FOR39
• B014FOR33: FOR33
• B014FOR27: FOR27
• B014FOR21: FOR21
• B014FOL45: FOL45
• B014FOL39: FOL39
• B014FOL33: FOL33
• B014FOL27: FOL27
• B014FOL21: FOL21