FDA UDI
In Commercial Distribution
🇺🇸 United States
Klassic HD Acetabular Insert with XLPE
DI: 00814703015076
·
Model: 3503.46.028
·
TOTAL JOINT ORTHOPEDICS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Klassic HD Acetabular Insert with XLPE
- Primary DI
- 00814703015076
- Version / Model
- 3503.46.028
- Company Name
- TOTAL JOINT ORTHOPEDICS, INC.
- Labeler DUNS
- 078416717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-12
- Public Version
- 1
- Public Version Date
- 2018-07-13
- Public Version Status
- New
- Public Device Record Key
- f7e28911-3b5a-4ac2-b2f2-db9d3ffa4da8
Device Description
Acetabular Insert with XLPE, 28mm head, size 46mm
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented | Orthopedic | 888.3360 | 2 |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43168 | Non-constrained polyethylene acetabular liner | A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814703015076 | GS1 |
Customer Contacts
- Phone
- +1(801)486-6070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180929 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 28mm head, size 46mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The Klassic HD Hip System should be stored in a clean, dry location at room temperature