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OSSIOfiber® Trimmable Fixation Nail System
FDA UDIClass I (US FDA UDI)
by Ossio Ltd
Identity
- Trade Name
- OSSIOfiber® Trimmable Fixation Nail System FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm. Package contains: 2 Implants, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit. FDA UDI
- Model / Reference
- OF2012430S FDA UDI
- Description
- OSSIOfiber® Trimmable Fixation Nail System, 2.4x30mm. Package contains: 2 Implants, 1 Insertion Sleeve, 1 Bone Tamp, 1 Depth Gauge, 2 K-Wires, 1 Cannulated Drill Bit. FDA UDI
Identifiers
- Catalog Number
- OF2012430S FDA UDI
- Primary DI / UDI-DI
- 07290017630267 FDA UDI
- FDA Product Code
- OJH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Length — 30 Millimeter FDA UDIOuter Diameter — 2.4 Millimeter FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, single-useOrthopaedic bone pin, bioabsorbable
OSSIOfiber® Trimmable Fixation Nail System by Ossio Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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 (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 I | Pending data |
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Manufacturer
- Manufacturer
- Ossio Ltd
Sources (1)
- FDA UDI 3689e664-72d6-4466-af7b-c1fe67448772 37 fields · synced May 31, 2026