AccessGUDID - DEVICE: Klassic Knee Tibial Stem Extension, 125mm (00814703011504)

GUDID

Device Identifier (DI) Information

Brand Name: Klassic Knee Tibial Stem Extension, 125mm
Version or Model: 5600.00.125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00814703011504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: No description.

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:	Yes
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?
64152	Knee tibia stem prosthesis	An implantable uncoated shaft-like device intended to be attached to the tibial baseplate of a modular knee tibia prosthesis to provide anchorage within the tibia. It has a threaded proximal end and is shaped to provide a tight fit with the internal tibial cortex; it is made of metallic materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140942	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: The Klassic Knee System should be stored in a clean, dry location at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 125mm

Device Record Status

Public Device Record Key: 4b2c7c85-32a8-4e3a-98ac-6cc2641c2032
Public Version Date: May 09, 2022
Public Version Number: 5
DI Record Publish Date: October 22, 2015