28mm x 11mm x 9mm Oblique with Inserter

FDA UDI

Class II (US FDA UDI)

by Xenco Medical Llc

Identity

Trade Name: 28mm x 11mm x 9mm Oblique with Inserter FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: 28mm x 11mm x 9mm Straight TLIF with Inserter FDA UDI
Model / Reference: XM-011-2809 FDA UDI
Description: 28mm x 11mm x 9mm Straight TLIF with Inserter FDA UDI

Identifiers

Primary DI / UDI-DI: B064XM01128091 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

28mm x 11mm x 9mm Oblique with Inserter by Xenco Medical 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: Xenco Medical Llc

Sources (1)

FDA UDI 0712dc91-ab4d-4951-9da8-4b44e2ad96c4 34 fields · synced May 30, 2026