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DartFire Edge

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
DartFire Edge FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Device Name
Cannulated Screw FDA UDI
Model / Reference
D0340046 FDA UDI
Description
Cannulated Screw FDA UDI

Identifiers

Catalog Number
D0340046 FDA UDI
Primary DI / UDI-DI
00889797083102 FDA UDI
510(k) Number
K203228 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile 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

No

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 46 Millimeter FDA UDI
Outer Diameter — 4 Millimeter FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

The DartFire Edge is a cannulated screw used for internal orthopaedic fracture fixation, providing compression across bone fragments. It is made of implantable non-bioabsorbable material and is designed for use in medical applications.

Similar devices

Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.

Cleared under the same submission

K203228 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wright Medical Technology, Inc.

Sources (1)

  • FDA UDI 633b93c8-d567-4ecb-a0f2-38d02a4f1f2c 37 fields · synced Jul 10, 2026