Identity
- Trade Name
- SmartNail Self-Reinforced Technology FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- SmartNail Self-Reinforced Technology Ø2.4 x 35 mm FDA UDI
- Model / Reference
- 532435 FDA UDI
- Description
- SmartNail Self-Reinforced Technology Ø2.4 x 35 mm FDA UDI
Identifiers
- Catalog Number
- 532435 FDA UDI
- Primary DI / UDI-DI
- 10845854015018 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Orthopaedic bone pin, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDIOuter Diameter — 2.4 Millimeter FDA UDI
Category: Orthopaedic bone pin, bioabsorbable
SmartNail Self-Reinforced Technology by Conmed Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone pin, bioabsorbable.
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- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
- Inion FreedomPin™ — Inion , Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI 283aee2c-9891-4fe2-b30a-0737f0184c46 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026