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OSSIOfiber™ Hammertoe Fixation Implant
FDA UDIClass II (US FDA UDI)
by Ossio Ltd
Identity
- Trade Name
- OSSIOfiber™ Hammertoe Fixation Implant FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- The OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). FDA UDI
- Model / Reference
- 2.9X19 mm straight FDA UDI
- Description
- The OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). FDA UDI
Identifiers
- Catalog Number
- OF10129190 FDA UDI
- Primary DI / UDI-DI
- 07290017630007 FDA UDI
- 510(k) Number
- K181180 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
- 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 — 19 Millimeter FDA UDIOuter Diameter — 2.9 Millimeter FDA UDI
Category: Orthopaedic bone pin, bioabsorbable
OSSIOfiber™ Hammertoe Fixation Implant by Ossio Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ossio Ltd
Sources (1)
- FDA UDI 78d7e0f8-765f-42dc-be01-d21b0d98c6b5 38 fields · synced May 31, 2026