FDA UDI
In Commercial Distribution
🇺🇸 United States
Mectacer Biolox Option Heads
DI: 07630030809392
·
Model: 01.29.242A
·
Medacta International SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mectacer Biolox Option Heads
- Primary DI
- 07630030809392
- Version / Model
- 01.29.242A
- Company Name
- Medacta International SA
- Labeler DUNS
- 488227125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-11-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fd98b119-f392-4dca-aeae-e81eed90218f
Device Description
Sleeve Size L
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 |
|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59688 | Femoral head/stem prosthesis adaptor | A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630030809392 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131518 | 000 |