← Back to catalogue

Orion Headed Screw

FDA UDI

Class II (US FDA UDI)

by Tyber Medical

Identity

Trade Name
Orion Headed Screw FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
ORION Ø4.0mm Headed Cannulated Screw, Long Thread, Ti – (L)40mm FDA UDI
Model / Reference
HTR-04-404940 FDA UDI
Description
ORION Ø4.0mm Headed Cannulated Screw, Long Thread, Ti – (L)40mm FDA UDI

Identifiers

Catalog Number
HTR-04-404940 FDA UDI
Primary DI / UDI-DI
M695HTR044049400 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Orion Headed Screw 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tyber Medical

Sources (1)

  • FDA UDI 0b26b688-e838-4a5a-8f9c-97fa58c0c4d5 35 fields · synced May 31, 2026