Identity
- Trade Name
- CALCANEA FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The CALCANEA locking screws are dedicated for the fixation of the CALCANEA Plate. They are made out of Titanium alloy and delivered non sterile. They are threaded heads adapted to the threaded holes of the plate. The range of screws include only one diameter of 3.5mm and a length from 20mm to 45mm (by 5mm). The fixation screws are self tapping, with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface. FDA UDI
- Model / Reference
- 180320ND FDA UDI
- Description
- The CALCANEA locking screws are dedicated for the fixation of the CALCANEA Plate. They are made out of Titanium alloy and delivered non sterile. They are threaded heads adapted to the threaded holes of the plate. The range of screws include only one diameter of 3.5mm and a length from 20mm to 45mm (by 5mm). The fixation screws are self tapping, with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface. FDA UDI
Identifiers
- Catalog Number
- 180320ND FDA UDI
- Primary DI / UDI-DI
- 10381780048367 FDA UDI
- 510(k) Number
- K041786 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Calcanea 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI a2c9c7a0-c56b-4cdf-ba3d-674e95ca8c52 39 fields · synced Jun 1, 2026