Identity
- Trade Name
- KALIX® FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- The size 17 stainles steel trial implant is used by the surgeon to choose the size of the final implant in the treatment of the hyperpronated foot and the stabilization of the subtalar joint. FDA UDI
- Model / Reference
- 119867ND FDA UDI
- Description
- The size 17 stainles steel trial implant is used by the surgeon to choose the size of the final implant in the treatment of the hyperpronated foot and the stabilization of the subtalar joint. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780051572 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
Yes
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
Kalix® by Newdeal Sas — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 82f8014d-e6f7-45a4-9f15-0dfd15460d57 36 fields · synced May 30, 2026