Tibiaxys®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: TIBIAXYS® FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: The 6mm thickness green colored anterior wedge, with a hexagonal attachment, is screwed into the tibial plate holes to position the plate at desired distance on the tibia during the talar part fixation. FDA UDI
Model / Reference: 159106ND FDA UDI
Description: The 6mm thickness green colored anterior wedge, with a hexagonal attachment, is screwed into the tibial plate holes to position the plate at desired distance on the tibia during the talar part fixation. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780052906 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

Tibiaxys® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI 80a61396-58ca-4d39-8aae-006355fefa26 36 fields · synced Jun 1, 2026