Ossera™ AFX

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: Ossera™ AFX FDA UDI
Generic Name: Metallic osteotomy fusion cage, non-customized FDA UDI
Device Name: Ossera™ AFX, Pill, 36x34 FDA UDI
Model / Reference: 1742-3634-N FDA UDI
Description: Ossera™ AFX, Pill, 36x34 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097517322 FDA UDI
510(k) Number: K242356 FDA UDI
FDA Product Code: SAI FDA UDI
GMDN Term: Metallic osteotomy fusion cage, non-customized FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Metallic osteotomy fusion cage, non-customized

The Ossera AFX is a non-customized metallic osteotomy fusion cage designed to facilitate bone fusion and alignment in the treatment of complex fractures, particularly those involving long bones. This innovative device features a small, wedge-shaped cylinder made of titanium (Ti) and is intended for implantation between the severed ends of a long bone.

Similar devices

Also classified as Metallic osteotomy fusion cage, non-customized.

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4WEB Medical — 4Web Medical, Inc. · Class II
Paragon 28 Bone Wedge System — Paragon 28 · Class II
4WEB Medical — 4Web Medical, Inc. · Class II
BIOFOAM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Foot Osteotomy Wedge System — Tyber Medical · Class II
4WEB Medical — 4Web Medical, Inc. · Class II

Cleared under the same submission

K242356 also covers:

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: Restor3D

Sources (1)

FDA UDI 42991348-7404-4844-a3a8-3919ee5cf763 34 fields · synced Jul 22, 2026