Genesys Spine Apache® Interbody Fusion System

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name: Genesys Spine Apache® Interbody Fusion System FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: Cervical Star Rasp - 14mm FDA UDI
Model / Reference: 1 FDA UDI
Description: Cervical Star Rasp - 14mm FDA UDI

Identifiers

Catalog Number: GP630-14 FDA UDI
Primary DI / UDI-DI: M719GP630140 FDA UDI
510(k) Number: K153123 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Bone file/rasp, manual, reusable 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

FDA UDI

Single Use

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: Length — 14 Millimeter FDA UDI

Category: Bone file/rasp, manual, reusable

Genesys Spine Apache® Interbody Fusion System by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone file/rasp, manual, reusable.

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DeGen Standard Instrumentation — Degen Medical · Class I
TiWave C Cervical Cage System — Kalitec Direct LLC · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
4WEB Medical — 4Web Medical, Inc. · Class I

Cleared under the same submission

K153123 also covers:

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 5a4e7d8a-6913-4a3d-8151-49bef868dc51 37 fields · synced May 30, 2026