AccessGUDID - DEVICE: Klassic Femoral Augment Screw, Distal (00814703019982)

GUDID

Device Identifier (DI) Information

Brand Name: Klassic Femoral Augment Screw, Distal
Version or Model: 6407.00.005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL JOINT ORTHOPEDICS, INC.

Primary DI Number: 00814703019982
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078416717 *Terms of Use

Device Description: Femoral Augment Screw, Distal, 5mm

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?
63998	Implantable orthopaedic/craniofacial device connection screw	A small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically made of metal and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other end.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 [?]
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: 5mm

Device Record Status

Public Device Record Key: 74269c29-4f8a-48c7-b15a-808e647f6dee
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: June 03, 2024