OSSIOfiber® Compression Staple System

FDA UDI

Class I (US FDA UDI)

by Ossio Ltd

Identity

Trade Name: OSSIOfiber® Compression Staple System FDA UDI
Generic Name: Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name: OSSIOfiber® Compression Staple System, 15 x 15 mm. Package contains: 1 Implant, and 1 Instrument pack. FDA UDI
Model / Reference: OF2061515S FDA UDI
Description: OSSIOfiber® Compression Staple System, 15 x 15 mm. Package contains: 1 Implant, and 1 Instrument pack. FDA UDI

Identifiers

Catalog Number: OF2061515S FDA UDI
Primary DI / UDI-DI: 07290017630694 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

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

Category: Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic bone staple, non-adjustable

OSSIOfiber® Compression Staple System by Ossio Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic bone staple, non-adjustable.

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JAWS Nitinol Staple System — Paragon 28 · 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 4b18184b-ae68-48c9-b9a8-72e609eebdc4 37 fields · synced Jun 8, 2026