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Snap-Off Screw System

FDA UDI

Class II (US FDA UDI)

by Treace Medical Concepts, Inc.

Identity

Trade Name
Snap-Off Screw System FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
2.0mm Snap-Off Screw System FDA UDI
Model / Reference
SK21 FDA UDI
Description
2.0mm Snap-Off Screw System FDA UDI

Identifiers

Primary DI / UDI-DI
00853114006143 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bone screw (non-sliding)

The Snap-Off Screw System is a high-quality, non-slip orthopedic bone screw designed for internal fixation of various limb bones. This compact screw system features a unique 2.0mm diameter, which provides excellent stability and comfort during implantation. The device is made from a cortically or cancellously designed material, ensuring optimal biocompatibility and resistance to corrosion.

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Treace Medical Concepts, Inc.

Sources (1)

  • FDA UDI ca6cd507-0555-4880-88c6-6d7fd3113c9c 33 fields · synced Jul 22, 2026