OSSIOfiber® Compression Screw

FDA UDI

Class II (US FDA UDI)

by Ossio Ltd

Identity

Trade Name: OSSIOfiber® Compression Screw FDA UDI
Generic Name: Bioabsorbable orthopaedic bone screw FDA UDI
Device Name: OSSIOfiber® Compression Screw, 3.5X12 mm. Package contains: 1 Implant. FDA UDI
Model / Reference: OF1073512S FDA UDI
Description: OSSIOfiber® Compression Screw, 3.5X12 mm. Package contains: 1 Implant. FDA UDI

Identifiers

Catalog Number: OF1073512S FDA UDI
Primary DI / UDI-DI: 07290017630922 FDA UDI
510(k) Number: K213596 FDA UDI
K231272 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Bioabsorbable orthopaedic bone screw 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.5 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Bioabsorbable orthopaedic bone screw

OSSIOfiber® Compression Screw by Ossio Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bioabsorbable orthopaedic bone screw.

MILAGRO — DePuy Mitek, Inc. · Class II
ActivaScrew™ — Bioretec Oy · Class II
MILAGRO — Medos International Sàrl · Class II
1.5 mm Inion CPS® Baby — Inion , Ltd. · Class II
Inion Hexalon™ — Inion , Ltd. · Class II
2.0 mm Inion CPS® — Inion , Ltd. · Class II
Arthrex® — Arthrex, Inc. · Class II
MILAGRO — Medos International Sàrl · Class II

Cleared under the same submission

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 5bad0222-4f36-4dcf-a297-40f52d52cf4e 38 fields · synced May 30, 2026