Identity
- Trade Name
- DuaFit® FDA UDI
- Generic Name
- Proximal interphalangeal joint prosthesis, one-piece FDA UDI
- Device Name
- Interphalangeal implants FDA UDI
- Model / Reference
- A60 SP103 B FDA UDI
- Description
- Interphalangeal implants FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701337603083 FDA UDI
- 510(k) Number
- K132912 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Proximal interphalangeal joint prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Dimensions & Sizes
- Size
- Angle — 10 degree FDA UDILength — 17 Millimeter FDA UDI
DuaFit® by In2bones — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- In2bones
Sources (1)
- FDA UDI 25a03791-229d-4413-862b-b611b3b64696 37 fields · synced Jun 8, 2026