AccessGUDID - DEVICE: OsteoBridge™ IKA Knee Arthrodesis Nail (04048266078902)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoBridge™ IKA Knee Arthrodesis Nail
Version or Model: without Collar 14 150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GA21415
Company Name: Merete GmbH

Primary DI Number: 04048266078902
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313267265 *Terms of Use

Device Description: TiAl6V4 ELI sterile

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):	No
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101939	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
Length: 150 Millimeter
Outer Diameter: 14 Millimeter

Device Record Status

Public Device Record Key: 887d9437-c8d8-4792-ab8f-47ec45b2360a
Public Version Date: May 12, 2023
Public Version Number: 7
DI Record Publish Date: October 15, 2015