Osteotomy Wedge

GUDID B014FOWR04

EMINENT SPINE LLC

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

• Primary Device ID: B014FOWR04
• NIH Device Record Key: ac17dc55-f083-4027-8d76-338f47a907e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotomy Wedge
• Version Model Number: FOWR04
• 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	B014FOWR04 [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

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

Moist Heat or Steam Sterilization

[B014FOWR04]

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 Wedge]

• B014FOWR08: FOWR08
• B014FOWR06: FOWR06
• B014FOWR04: FOWR04
• B014FOWR02: FOWR02
• B014FOWL08: FOWL08
• B014FOWL06: FOWL06
• B014FOWL04: FOWL04
• B014FOWL02: FOWL02