CannCompScrew 3.0mm (SelfDrill)

FDA UDI

Class II (US FDA UDI)

by Trimed, INC.

Identity

Trade Name: CannCompScrew 3.0mm (SelfDrill) FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Self-Drill CCScrew SThd 3.0, 34mm FDA UDI
Model / Reference: S3034 FDA UDI
Description: Self-Drill CCScrew SThd 3.0, 34mm FDA UDI

Identifiers

Catalog Number: S3034 FDA UDI
Primary DI / UDI-DI: 00842188122019 FDA UDI
510(k) Number: K050681 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

The CannCompScrew 3.0mm (SelfDrill) is a medical device designed for internal orthopedic fixation, allowing for direct interfragmentary stabilization of fractured bones in various limb bones, including the femur, humerus, tibia, fibula, sternum, and pelvis. With its self-drilling feature, it enables efficient implantation with minimal trauma to the surrounding tissue.

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

K050681 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: Trimed, INC.

Sources (1)

FDA UDI 5417fac3-f8d8-40cb-99eb-479bb251e3de 36 fields · synced Jul 23, 2026