FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOLOX CONTOURA Ceramic Femoral Head
DI: 00814703016899
·
Model: 3206.36.350
·
TOTAL JOINT ORTHOPEDICS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIOLOX CONTOURA Ceramic Femoral Head
- Primary DI
- 00814703016899
- Version / Model
- 3206.36.350
- Company Name
- TOTAL JOINT ORTHOPEDICS, INC.
- Labeler DUNS
- 078416717
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-16
- Public Version
- 2
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- c0297293-32f2-428f-8f4b-7564fd3130cd
Device Description
Contura Femoral Head, 36mm head, +3.5mm head length
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
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous | Orthopedic | 888.3358 | 2 |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | Orthopedic | 888.3353 | 2 |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38156 | Ceramic femoral head prosthesis | An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814703016899 | GS1 |
Customer Contacts
- Phone
- +1(801)486-6070
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191399 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | +3.5mm head length |
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