Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- 4.5/200/50mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA FDA UDI
- Model / Reference
- 11-705-950200S FDA UDI
- Description
- 4.5/200/50mm Half Pin, Self-Drilling/Self-Tapping, QC, SS, HA FDA UDI
Identifiers
- Catalog Number
- 11-705-950200S FDA UDI
- Primary DI / UDI-DI
- B56211705950200S0 FDA UDI
- 510(k) Number
- K231461 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use 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
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
No
FDA UDI
MR Unsafe 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 20d25d0c-d08a-435c-aec3-08684fea3c6e 36 fields · synced Jun 8, 2026