AccessGUDID - DEVICE: Endo Model Knee Fusion Nail FK (04026575346738)

GUDID

Device Identifier (DI) Information

Brand Name: Endo Model Knee Fusion Nail FK
Version or Model: 15-8431/21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15-8431/21
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575346738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Femoral Component

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?
58085	Knee arthrodesis prosthesis	A fused (non-articulating) replacement for the knee joint intended to be implanted after failed primary knee arthroplasty and which functions as a bridge between the resected metaphyses of the femur and tibia. It is a modular device that typically includes resection elements (spacers), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.	Obsolete	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 [?]
K151008	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 46bc97c8-0f30-41cc-9aad-7c8e77df7446
Public Version Date: July 02, 2025
Public Version Number: 2
DI Record Publish Date: January 12, 2021