FDA UDI
In Commercial Distribution
🇺🇸 United States
LCS COMPLETE AOX
DI: 10603295023944
·
Model: 1294-18-110
·
DEPUY ORTHOPAEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LCS COMPLETE AOX
- Primary DI
- 10603295023944
- Version / Model
- 1294-18-110
- Catalog Number
- 129418110
- Company Name
- DEPUY ORTHOPAEDICS, INC.
- Labeler DUNS
- 080506581
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-24
- Public Version
- 5
- Public Version Date
- 2021-10-11
- Public Version Status
- Update
- Public Device Record Key
- 8b79caaf-03e8-4c85-95c2-acf3f84a4ff6
Device Description
LCS COMPLETE TIBIAL INSERT ROTATING PLATFORM RP AOX SM 10mm
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
- 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 |
|---|---|---|---|---|
| NJL | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46585 | Tibial insert | An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295023944 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]