Athlet

FDA UDI

Class II (US FDA UDI)

by SIGNUS Medizintechnik GmbH

Identity

Trade Name: ATHLET FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth. FDA UDI
Model / Reference: Connection screw FDA UDI
Description: The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth. FDA UDI

Identifiers

Catalog Number: ATM309 FDA UDI
Primary DI / UDI-DI: 04047844002414 FDA UDI
FDA Product Code: MQP FDA UDI
ODP FDA UDI
OVE FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
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

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

Yes

FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Athlet by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II

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: SIGNUS Medizintechnik GmbH

Sources (1)

FDA UDI e2d36e3e-adea-4726-93b1-f566be1b8ae9 37 fields · synced May 30, 2026