FDA UDI
In Commercial Distribution
🇺🇸 United States
TrabecuLink Augments
DI: 04026575267439
·
Model: 185-044/10
·
WALDEMAR LINK GmbH & Co. KG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TrabecuLink Augments
- Primary DI
- 04026575267439
- Version / Model
- 185-044/10
- Catalog Number
- 185-044/10
- Company Name
- WALDEMAR LINK GmbH & Co. KG
- Labeler DUNS
- 315675488
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-13
- Public Version
- 1
- Public Version Date
- 2025-01-21
- Public Version Status
- New
- Public Device Record Key
- a80dfd8a-5681-4b9d-a139-e873b51edf90
Device Description
Acetabular augment, Ti6Al4V - 3D-printed
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | 888.3353 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04026575267439 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241636 | 000 |