AccessGUDID - DEVICE: Klassic Stem Adapter, Femoral (00814703019654)

GUDID

Device Identifier (DI) Information

Brand Name: Klassic Stem Adapter, Femoral
Version or Model: 6602.00.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00814703019654
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: Stem Adapter, Femoral

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?
62865	Knee femur stem/sleeve connector	A sterile implantable device intended to provide a connection between a knee femur prosthesis and a knee stem or sleeve when the knee femur prosthesis does not have a connection point inherent in its design. It takes various forms including a plate and trunnion, or a cylinder, and is made of metal [e.g., cobalt-chrome (Co-Cr)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBH	PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
OIY	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230537	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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
No Device Sizes

Device Record Status

Public Device Record Key: fc249648-5bfb-46e4-8ae3-c539153f84c0
Public Version Date: June 01, 2023
Public Version Number: 1
DI Record Publish Date: May 24, 2023