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OSSIOfiber® Trimmable Fixation Nail, Cannulated
FDA UDIClass II (US FDA UDI)
by Ossio Ltd
Identity
- Trade Name
- OSSIOfiber® Trimmable Fixation Nail, Cannulated FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant. FDA UDI
- Model / Reference
- OF1054100S FDA UDI
- Description
- OSSIOfiber® Trimmable Fixation Nail, 4.0x100mm, Cannulated. Package contains: 1 Implant. FDA UDI
Identifiers
- Catalog Number
- OF1054100S FDA UDI
- Primary DI / UDI-DI
- 07290019361060 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
- Outer Diameter — 4.0 Millimeter FDA UDILength — 100 Millimeter FDA UDI
Category: Orthopaedic bone pin, bioabsorbable
OSSIOfiber® Trimmable Fixation Nail, Cannulated by Ossio Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, bioabsorbable.
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- ActivaPin™ — Bioretec Oy · Class II
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
- Inion FreedomPin™ — Inion , Ltd. · Class II
Cleared under the same submission
K231272 also covers:
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
- OSSIOfiber® Compression Screw — OSSIO LTD
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 7d5dbf38-caf5-4d38-a8e6-96c7e6622a30 38 fields · synced May 30, 2026