Inion SPINE instrumentation

FDA UDI

Class I (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name: Inion SPINE instrumentation FDA UDI
Generic Name: Surgical cutting/shaping board, reusable FDA UDI
Device Name: Plate contouring block FDA UDI
Model / Reference: 1 FDA UDI
Description: Plate contouring block FDA UDI

Identifiers

Catalog Number: ACC-9843 FDA UDI
Primary DI / UDI-DI: 06438408005107 FDA UDI
FDA Product Code: HXP FDA UDI
GMDN Term: Surgical cutting/shaping board, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical cutting/shaping board, reusable

Inion SPINE instrumentation by Inion , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical cutting/shaping board, reusable.

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MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Preparation tray, stainless steel — Spiggle & Theis Medizintechnik GmbH · Class I
Gyrus ACMI — Gyrus Acmi, Inc. · Class I
V. Mueller — STERIS CORPORATION · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Inion , Ltd.

Sources (1)

FDA UDI efaed12e-0af1-4875-8ea5-989c4bcfae1e 34 fields · synced Jun 6, 2026