4.0 x 115mm LOCKING BONE SCREW FASTENER ST

FDA UDI

Class II (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: 4.0 x 115mm LOCKING BONE SCREW FASTENER ST FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: 4.0 x 115mm LOCKING BONE SCREW FASTENER, ST FDA UDI
Model / Reference: 340-6115 FDA UDI
Description: 4.0 x 115mm LOCKING BONE SCREW FASTENER, ST FDA UDI

Identifiers

Catalog Number: 340-6115 FDA UDI
Primary DI / UDI-DI: 00816950027727 FDA UDI
510(k) Number: K190430 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

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

Dimensions & Sizes

Size: Length — 115 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

A comprehensive 2-3 paragraph SEO description written in clear, natural language. The 4.0 x 115mm LOCKING BONE SCREW FASTENER ST is a non-sliding orthopaedic bone screw designed for internal fixation by being screwed into limb bones to hold plates, nails, or rods to the bone or provide direct interfragmentary stabilization.

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

K190430 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: OsteoCentric Technologies, Inc

Sources (1)

FDA UDI 19757ad9-9d30-4f9a-804c-ebf68244b647 37 fields · synced Jul 1, 2026