Construx - Mini Ptc

FDA UDI

Class II (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name: CONSTRUX - MINI PTC FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: 12mm L X 12mm W, 11mm H Lordotic Implant FDA UDI
Model / Reference: 37-3010SP FDA UDI
Description: 12mm L X 12mm W, 11mm H Lordotic Implant FDA UDI

Identifiers

Primary DI / UDI-DI: 18257200030491 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 11 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Vertebral body prosthesis, non-sterile

Construx - Mini Ptc by Orthofix US LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Orthofix US LLC

Sources (1)

FDA UDI b84c8307-ea5e-4dcf-912e-e531a0093696 35 fields · synced May 31, 2026