Identity
- Trade Name
- Forefoot FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- The principal of the FOREFOOT sets is to propose a group of implants (screws and staples) and the associated instruments in a single package dedicated to the forefoot orthopaedic surgery. The set is intended to make easy the surgeon work and give more solution in the same set. The Forefoot Set includes Bold compression screws, QWIX fixation screws, Spin snap-off screws, Solustaple, Uni-clip staples, and instrumentation. FDA UDI
- Model / Reference
- FFINSTSET FDA UDI
- Description
- The principal of the FOREFOOT sets is to propose a group of implants (screws and staples) and the associated instruments in a single package dedicated to the forefoot orthopaedic surgery. The set is intended to make easy the surgeon work and give more solution in the same set. The Forefoot Set includes Bold compression screws, QWIX fixation screws, Spin snap-off screws, Solustaple, Uni-clip staples, and instrumentation. FDA UDI
Identifiers
- Catalog Number
- FFINSTSET FDA UDI
- Primary DI / UDI-DI
- 10381780064398 FDA UDI
- FDA Product Code
- HTY FDA UDIHWC FDA UDIJDR FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Forefoot 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 c33f8248-beed-49f1-ad30-210515bd0227 37 fields · synced May 30, 2026