StabilizOrtho

FDA UDI

Class II (US FDA UDI)

by Stabiliz Orthopaedics

Identity

Trade Name: StabilizOrtho FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: SimpliFix Cannulated Screw 8.3mm x 110mm FDA UDI
Model / Reference: SFX83110 FDA UDI
Description: SimpliFix Cannulated Screw 8.3mm x 110mm FDA UDI

Identifiers

Primary DI / UDI-DI: B650SFX831100 FDA UDI
510(k) Number: K230053 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) 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

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

Category: Orthopaedic bone screw (non-sliding)

StabilizOrtho by Stabiliz Orthopaedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · 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

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

Manufacturer

Manufacturer: Stabiliz Orthopaedics

Sources (1)

FDA UDI 4f49557b-4212-440e-9c9f-7743258a1a9e 34 fields · synced May 30, 2026