spineEOS rod Template /

GUDID 03700757200766

spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software. This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience.

ONEFIT MEDICAL

Surgical implant template, single-use

• Primary Device ID: 03700757200766
• NIH Device Record Key: 63629a11-9dd1-4564-82ab-6fe4192bce1d
• Commercial Distribution Discontinuation: 2021-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: spineEOS rod Template
• Version Model Number: KIT0704
• Catalog Number: /
• Company DUNS: 263373588
• Company Name: ONEFIT MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com
• Phone: +33381252427
• Email: contact@onefit-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700757200766 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-02
• Device Publish Date: 2017-02-23

On-Brand Devices [spineEOS rod Template]

• 03700757200803: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200797: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200780: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200773: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200766: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200759: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200650: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o
• 03700757200643: spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in o