OSSIOfiber® Trimmable Fixation Nail System, Cannulated

FDA UDI

Class I (US FDA UDI)

by Ossio Ltd

Identity

Trade Name: OSSIOfiber® Trimmable Fixation Nail System, Cannulated FDA UDI
Generic Name: Orthopaedic bone pin, bioabsorbable FDA UDI
Device Name: OSSIOfiber® Trimmable Fixation Nail System, 4.0x100mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack. FDA UDI
Model / Reference: OF2054100S FDA UDI
Description: OSSIOfiber® Trimmable Fixation Nail System, 4.0x100mm, Cannulated. Package contains: 1 Implant, and 1 instrument pack. FDA UDI

Identifiers

Catalog Number: OF2054100S FDA UDI
Primary DI / UDI-DI: 07290019361022 FDA UDI
FDA Product Code: OJH FDA UDI
GMDN Term: Orthopaedic bone pin, bioabsorbable 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 100 Millimeter FDA UDI
Outer Diameter — 4.0 Millimeter FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic bone pin, bioabsorbable

OSSIOfiber® Trimmable Fixation Nail System, Cannulated by Ossio Ltd — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Ossio Ltd

Sources (1)

FDA UDI ccb60bb2-b2f2-42c2-9a7c-d0c906be77d7 37 fields · synced May 30, 2026