FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Patient-Specific TMJ Fossa-Eminence Prosthesis (RIGHT SIDE)
DI: M9575001060
·
Model: 500106
·
Nexus Cmf, L.L.C.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Patient-Specific TMJ Fossa-Eminence Prosthesis (RIGHT SIDE)
- Primary DI
- M9575001060
- Version / Model
- 500106
- Company Name
- Nexus Cmf, L.L.C.
- Labeler DUNS
- 965540227
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-10-15
- Public Version
- 5
- Public Version Date
- 2020-11-25
- Public Version Status
- Update
- Public Device Record Key
- 5f0ec557-6c78-4ac0-a5a4-8831f1de5684
- Distribution End Date
- 2017-05-31
Device Description
Patient-Specific TMJ Fossa-Eminence Prosthesis (RIGHT SIDE)
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 |
|---|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | Dental | 872.3940 | 3 |
| MPI | Glenoid Fossa Prosthesis | Dental | 872.3950 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55825 | Mandibular fossa prosthesis | A sterile implantable component of a total temporomandibular joint (TMJ) prosthesis designed to replace or repair the articulating surface of the joint comprised of the glenoid fossa and the articulating eminence of the temporal bone. It is cup-like in shape and typically made of polyethylene (PE); it may include screws for attachment to temporal bone. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M9575001060 | HIBCC |