FDA.reportPublic FDA data

spineEOS rod Template

Primary DI
03700757200797
Brand
spineEOS rod Template
Company
ONEFIT MEDICAL
Model
KIT0707
Catalog number
/
Device description
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.
Published
2017-02-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700757200797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700757200797037007572007973700757200797

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33381252427contact@onefit-medical.com

Regulatory Flags#

DUNS number
263373588
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700757200506kneeEOS1.02016-10-11
03700757200520hipEOS2.52016-09-26
03700757200544spineEOS1.12016-09-26
03700757200643spineEOS rod TemplateKIT0701/2017-02-23
03700757200650spineEOS rod TemplateKIT0702/2017-02-23
03700757200759spineEOS rod TemplateKIT0703/2017-02-23
03700757200766spineEOS rod TemplateKIT0704/2017-02-23
03700757200773spineEOS rod TemplateKIT0705/2017-02-23
03700757200780spineEOS rod TemplateKIT0706/2017-02-23
03700757200803spineEOS rod TemplateKIT0708/2017-02-23
03700757200827hipEOS2.x/2017-02-13
03700757200834hipEOS3.x2018-05-24
03700757200858spineEOS1.x2017-06-27

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