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: ALIF Trial FDA UDI
Model / Reference: 1 FDA UDI
Description: ALIF Trial FDA UDI

Identifiers

Catalog Number: GP0616 FDA UDI
Primary DI / UDI-DI: M719GP06160 FDA UDI
FDA Product Code: MAX FDA UDI
MQP FDA UDI
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
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

Dimensions & Sizes

Size: Angle — 6 degree FDA UDI
Length — 16 Millimeter 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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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 fec772f7-f656-4fe4-a0ef-dccc803e248c 36 fields · synced May 31, 2026