Arx

FDA UDI

Class II (US FDA UDI)

by Life Spine, Inc.

Identity

Trade Name: Arx FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Device Name: Set Screw Provisional Driver - Long FDA UDI
Model / Reference: 175-120 FDA UDI
Description: Set Screw Provisional Driver - Long FDA UDI

Identifiers

Catalog Number: 175-120 FDA UDI
Primary DI / UDI-DI: 00190837035969 FDA UDI
510(k) Number: K061600 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 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

Category: Surgical screwdriver, reusable

Arx by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical screwdriver, reusable.

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Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
PERLA ® TL — Spineart · Class II
USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I

Cleared under the same submission

K061600 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: Life Spine, Inc.

Sources (1)

FDA UDI e08b8d13-93b8-4dc0-9253-400acc8e2436 35 fields · synced May 31, 2026