AccessGUDID - DEVICE: TrabecuLink Augments (04026575267583)

GUDID

Device Identifier (DI) Information

Brand Name: TrabecuLink Augments
Version or Model: 185-058/15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 185-058/15
Company Name: WALDEMAR LINK GmbH & Co. KG

Primary DI Number: 04026575267583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315675488 *Terms of Use

Device Description: Acetabular augment, Ti6Al4V - 3D-printed

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?
61780	Acetabular augmentation implant	A sterile implantable device intended to help prevent dislocation of a total hip replacement by augmenting the posterior lip of the acetabulum around a retained acetabular prosthesis, or to help fill bone defects not covered by the acetabular prosthesis. It is designed to help constrain the femoral head and/or provide additional support for the acetabular prosthesis. It is available in various shapes, is typically made of metal [e.g. Titanium alloy] and/or polymer, and may be fixed with screws and/or cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241636	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: 63182c4e-bf1a-47bc-89b7-69181811a00d
Public Version Date: January 21, 2025
Public Version Number: 1
DI Record Publish Date: January 13, 2025