Identity
- Trade Name
- BASAL DORSAL PLATE FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is available in different sizes. It is implanted using Newdeal locking system fixation screws and washers. The screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head. FDA UDI
- Model / Reference
- 116110SND FDA UDI
- Description
- The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is available in different sizes. It is implanted using Newdeal locking system fixation screws and washers. The screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head. FDA UDI
Identifiers
- Catalog Number
- 116110SND FDA UDI
- Primary DI / UDI-DI
- 10381780043331 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
FDA UDI
Basal Dorsal Plate by Newdeal Sas — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 16ab2de3-b9c1-49ce-a3c5-de8ad1a7ee2d 38 fields · synced May 31, 2026