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Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE) FDA UDI
- Generic Name
- Mandibular condyle prosthesis FDA UDI
- Device Name
- Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE) FDA UDI
- Model / Reference
- 500109 FDA UDI
- Description
- Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9575001090 FDA UDI
- FDA Product Code
- LZD FDA UDI
- GMDN Term
- Mandibular condyle prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 872.3940 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE) by Nexus Cmf, L.L.C. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Nexus Cmf, L.L.C.
Sources (1)
- FDA UDI 33ee1d7f-2df8-412e-bcf1-6b4bc4bade1c 34 fields · synced May 30, 2026