FDA UDI
In Commercial Distribution
🇺🇸 United States
X-PSI Knee
DI: 00887868557590
·
Model: 803.308
·
Orthosoft Inc
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X-PSI Knee
- Primary DI
- 00887868557590
- Version / Model
- 803.308
- Catalog Number
- 803.308
- Company Name
- Orthosoft Inc
- Labeler DUNS
- 205670032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-11
- Public Version
- 1
- Public Version Date
- 2022-08-19
- Public Version Status
- New
- Public Device Record Key
- 140bf24c-0e7a-4977-b300-33bd5ea02ceb
Device Characteristics
- Single Use
- No
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | 888.3565 | 2 |
| OOG | Knee Arthroplasty Implantation System | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 50484 | CAD/CAM software | A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887868557590 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171269 | 000 |