FDA UDI
In Commercial Distribution
🇺🇸 United States
Rx Knee AP Symmetrical Augment Size 5 - 12mm Titanium Half Draft Right
DI: 09348215111762
·
Model: 121-20-9295
·
SIGNATURE ORTHOPAEDICS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rx Knee AP Symmetrical Augment Size 5 - 12mm Titanium Half Draft Right
- Primary DI
- 09348215111762
- Version / Model
- 121-20-9295
- Company Name
- SIGNATURE ORTHOPAEDICS PTY LTD
- Labeler DUNS
- 751993028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-19
- Public Version
- 2
- Public Version Date
- 2025-04-11
- Public Version Status
- Update
- Public Device Record Key
- 15f3c9ac-7893-4464-945f-6b280e09beec
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67099 | Temporary knee prosthesis, non-customized | A prefabricated, implantable device that includes a pharmaceutical antibiotic agent (e.g., gentamicin) intended to be used as a temporary substitute for a knee prosthesis to: 1) provide a means for limited mobility/weight-bearing; and 2) release the antibiotic agent to the periprosthetic space to treat infection as part of a revision orthopaedic surgery. Also known as a spacer, it may include knee femur and/or tibial components, and is made of metallic and/or polymer materials. Following infection treatment and device explantation, a definitive prosthesis is implanted. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09348215111762 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240683 | 000 |