Identity
- Trade Name
- RFS™ Pin FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- RFS™ Pin 2.7 x 50 mm FDA UDI
- Model / Reference
- RFS-P027 FDA UDI
- Description
- RFS™ Pin 2.7 x 50 mm FDA UDI
Identifiers
- Catalog Number
- RFS-P027 FDA UDI
- Primary DI / UDI-DI
- E302RFSP0279 FDA UDI
- 510(k) Number
- K080879 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, bioabsorbable 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
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIWidth — 2.7 Millimeter FDA UDI
RFS™ Pin by Bioretec Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K080879 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioretec Oy
Sources (1)
- FDA UDI c58d5dd5-aca5-4b61-809f-9b72ca3de3fd 39 fields · synced Jun 1, 2026