Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- External orthopaedic fixation frame calculation software FDA UDI
- Device Name
- Click2Correct/ Smart Correction software FDA UDI
- Model / Reference
- C2C20210 FDA UDI
- Description
- Click2Correct/ Smart Correction software FDA UDI
Identifiers
- Primary DI / UDI-DI
- B562C2C20210 FDA UDI
- FDA Product Code
- OSN FDA UDI
- GMDN Term
- External orthopaedic fixation frame calculation software 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Smart Correction by Wishbone Medical Inc. — 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
- Wishbone Medical Inc.
Sources (1)
- FDA UDI 8ca08757-58f4-431e-855f-41b6f97ba8fa 34 fields · synced May 30, 2026