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 3 FDA UDI
Model / Reference: SC010333 FDA UDI
Description: STERN FIX Sternal Stabilization System- size 3 FDA UDI

Identifiers

Primary DI / UDI-DI: 08437006085465 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

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Manufacturer

Manufacturer: Neos Surgery Sl

Sources (1)

FDA UDI d1d13773-e9b6-4da4-9b5c-9ef5d8dc54fd 36 fields · synced May 30, 2026