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LEOS Cannulated Screw System

FDA UDI

Class II (US FDA UDI)

by Tyber Medical

Identity

Trade Name
LEOS Cannulated Screw System FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
LEOS 7.0 X 76mm HD Cann Screw, FT, Ti FDA UDI
Model / Reference
76337076FT FDA UDI
Description
LEOS 7.0 X 76mm HD Cann Screw, FT, Ti FDA UDI

Identifiers

Catalog Number
76337076FT FDA UDI
Primary DI / UDI-DI
00196449004812 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

LEOS Cannulated Screw System by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 9cdd541d-6b0c-4b60-ba7e-93e08b672f33 35 fields · synced May 30, 2026