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Cannulated Screw System +

FDA UDI

Class II (US FDA UDI)

by Tyber Medical

Identity

Trade Name
Cannulated Screw System + FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
6.5MM TI CANN SCREW + LT - 175MM FDA UDI
Model / Reference
04.354.715 FDA UDI
Description
6.5MM TI CANN SCREW + LT - 175MM FDA UDI

Identifiers

Catalog Number
04.354.715 FDA UDI
Primary DI / UDI-DI
00810040683329 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

The Cannulated Screw System + is a medical device designed for internal orthopedic fixation, providing direct interfragmentary stabilization of fractured bones. It consists of a small, threaded, non-bioabsorbable rod intended for screwing into limb bones, ribs, sternum, and/or pelvis to hold plates, nails, rods or prosthesis.

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
Tyber Medical

Sources (1)

  • FDA UDI fc529e02-ee71-465b-b48e-0ba2c4d3e828 35 fields · synced Aug 4, 2026