Identity
- Trade Name
- HALLU-FIX FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The sterile HALLU-S plates are available in different sizes (left/right). They are both low profile titanium alloy plates dedicated to the first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation and they are contoured for optimal bone coverage. They are implanted using SNAP-OFF screws which exist in different diameters and sizes. FDA UDI
- Model / Reference
- 117160SND FDA UDI
- Description
- The sterile HALLU-S plates are available in different sizes (left/right). They are both low profile titanium alloy plates dedicated to the first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation and they are contoured for optimal bone coverage. They are implanted using SNAP-OFF screws which exist in different diameters and sizes. FDA UDI
Identifiers
- Catalog Number
- 117160SND FDA UDI
- Primary DI / UDI-DI
- 10381780043409 FDA UDI
- 510(k) Number
- K093781 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
- 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
Category: Orthopaedic fixation plate, non-bioabsorbable
Hallu-Fix by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 a1adbeb2-b298-4aba-bfef-b4a4e15af214 39 fields · synced Jun 8, 2026