Apache

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name: Apache FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: Apache Cervical 2-L System FDA UDI
Model / Reference: 1 FDA UDI
Description: Apache Cervical 2-L System FDA UDI

Identifiers

Catalog Number: G4100 FDA UDI
Primary DI / UDI-DI: M719G41000 FDA UDI
FDA Product Code: ODP FDA UDI
MQP FDA UDI
MAX FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vertebral body prosthesis, non-sterile

Apache by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HONOUR™ Spacer System — NEXXT SPINE LLC · 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: Genesys Orthopedics Systems LLC

Sources (1)

FDA UDI b1cec28a-f3c6-46df-8b01-65b149a2441b 35 fields · synced Jun 6, 2026