Stern Fix

FDA UDI

Class II (US FDA UDI)

by Neos Surgery Sl

Identity

Trade Name: STERN FIX FDA UDI
Generic Name: Sternal fixation device FDA UDI
Device Name: STERN FIX Sternal Stabilization System, Size 2 FDA UDI
Model / Reference: SC010222 FDA UDI
Description: STERN FIX Sternal Stabilization System, Size 2 FDA UDI

Identifiers

Primary DI / UDI-DI: 08437006085458 FDA UDI
510(k) Number: K221795 FDA UDI
FDA Product Code: JDQ FDA UDI
GMDN Term: Sternal fixation device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3010 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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Sternal fixation device

Stern Fix by Neos Surgery Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sternal fixation device.

STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Vanguard® — Biomet Orthopedics, Inc. · Class I
ARIX Sternal System Bone Screw — Jeil Medical Corporation · Class II
ARIX Sternal System Bone Plate — Jeil Medical Corporation · Class II
SternaFuse® Fixation System — FUSION INNOVATIONS · Class II
Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II
STERNALOCK® BLU SYSTEM — BIOMET MICROFIXATION, INC · Class II
Valkyrie Thoracic Fixation System — J.M. Longyear Manufacturing, LLC · Class II

Cleared under the same submission

K221795 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Neos Surgery Sl

Sources (1)

FDA UDI 687c5ceb-6849-484d-810f-650e496dd3a0 36 fields · synced May 30, 2026