3.9mm x 28mm HCS

FDA UDI

Class II (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: 3.9mm x 28mm HCS FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: 3.9mm x 28mm Headless Compression Screw FDA UDI
Model / Reference: 801-23928 FDA UDI
Description: 3.9mm x 28mm Headless Compression Screw FDA UDI

Identifiers

Catalog Number: 801-23928 FDA UDI
Primary DI / UDI-DI: 00850015496608 FDA UDI
510(k) Number: K200259 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 — 28 Millimeter FDA UDI
Outer Diameter — 3.9 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

3.9mm x 28mm HCS by OsteoCentric Technologies, Inc — 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

K200259 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: OsteoCentric Technologies, Inc

Sources (1)

FDA UDI 8cdd2c26-b618-47a0-bad3-735c406f9f7b 37 fields · synced May 30, 2026