Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, single-use FDA UDI
- Device Name
- Slotted Tensioner Head FDA UDI
- Model / Reference
- 00-0182-04-WBNS FDA UDI
- Description
- Slotted Tensioner Head FDA UDI
Identifiers
- Catalog Number
- 00-0182-04-WBNS FDA UDI
- Primary DI / UDI-DI
- B56200018204WBNS0 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Smart Correction by Wishbone Medical Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI be1d4199-190e-403c-ac5d-6d88ed7e8f5d 35 fields · synced May 30, 2026