FDA UDI
In Commercial Distribution
🇺🇸 United States
Megasystem C
DI: 04026575383467
·
Model: 15-8523/70
·
WALDEMAR LINK GmbH & Co. KG
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Megasystem C
- Primary DI
- 04026575383467
- Version / Model
- 15-8523/70
- Catalog Number
- 15-8523/70
- 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
- 2015-11-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4520bebd-3aea-42f9-ba93-dc05a84f9cbe
Device Description
Stem Components,Push-through, for total femur replacement
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 |
|---|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3510 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | 888.3350 | 2 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58084 | Diaphysis prosthesis | An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04026575383467 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151008 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter=14mm, Length=120mm |