Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- Orthopaedic rod reducer FDA UDI
- Device Name
- Screw Height Adjuster, T-handle, T25 FDA UDI
- Model / Reference
- 09.0661 FDA UDI
- Description
- Screw Height Adjuster, T-handle, T25 FDA UDI
Identifiers
- Catalog Number
- 09.0661 FDA UDI
- Primary DI / UDI-DI
- B5620906610 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Orthopaedic rod reducer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization 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 91c8a2f7-4df6-41d8-aa44-a3f664b6884d 36 fields · synced May 30, 2026