FDA UDI
In Commercial Distribution
🇺🇸 United States
Oxford® Partial Knee System
DI: 05019279998296
·
Model: 32-423197
·
Biomet Uk Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Oxford® Partial Knee System
- Primary DI
- 05019279998296
- Version / Model
- 32-423197
- Catalog Number
- 32-423197
- Company Name
- Biomet Uk Ltd
- Labeler DUNS
- 219322575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-10
- Public Version
- 2
- Public Version Date
- 2025-05-30
- Public Version Status
- Update
- Public Device Record Key
- 5b3f03a2-3c91-4977-b7c7-4e13a7ca26ea
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRA | Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13180 | Orthopaedic prosthesis implantation positioning instrument, reusable | A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05019279998296 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010014 | 105 |