8.0 X 105mm Cann Screw Fastener 55mm Var Thd

FDA UDI

Class II (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: 8.0 X 105mm Cann Screw Fastener 55mm Var Thd FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: 8.0 X 105mm Cann Screw Fastener 55mm Var Thd FDA UDI
Model / Reference: 380-5105-055 FDA UDI
Description: 8.0 X 105mm Cann Screw Fastener 55mm Var Thd FDA UDI

Identifiers

Catalog Number: 380-5105-055 FDA UDI
Primary DI / UDI-DI: 00810074306836 FDA UDI
510(k) Number: K211290 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: Outer Diameter — 8.0 Millimeter FDA UDI
Length — 105 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

A comprehensive 2-3 paragraph SEO description written in clear, natural language.

This cann screw fastener is designed for internal orthopedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone. It is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, nor used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis.

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
AYSAM — Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi · Class IIb
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II

Cleared under the same submission

K211290 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 c75b90e4-6f0d-46d7-a8d3-db195a8df44b 37 fields · synced Oct 6, 2026