AccessGUDID - DEVICE: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (B278JTSDRIVEUNIT0)

GUDID

Device Identifier (DI) Information

Brand Name: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Version or Model: MLE3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: JTS-DRIVE-UNIT
Company Name: ONKOS SURGICAL, INC.

Primary DI Number: B278JTSDRIVEUNIT0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080254074 *Terms of Use
Previous DI: 05060296236007

Device Description: JTS Drive Unit Set

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37655	Extremity MRI system, resistive magnet	A diagnostic magnetic resonance imaging (MRI) system employing resistive magnet technology specifically designed to image only the head and neck or limbs. An extremity imaging system is typically closed bore design with cylindrical or rectangular bore openings but can be "open" bore design. This device includes MRI systems with conventional extremity capabilities, conventional systems capable of performing spectroscopy or other real-time imaging procedures necessary for interventional and therapeutic MRI applications, and dedicated magnetic resonance (MR) spectroscopy systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092138	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: af45b7c3-9705-4910-8686-989edd728df6
Public Version Date: July 30, 2024
Public Version Number: 1
DI Record Publish Date: July 22, 2024