Inion SPINE instrumentation

FDA UDI

Class I (US FDA UDI)

by Inion , Ltd.

Identity

Trade Name: Inion SPINE instrumentation FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: Drill bit 5.0 mm with stop for 31 mm screw FDA UDI
Model / Reference: 1 FDA UDI
Description: Drill bit 5.0 mm with stop for 31 mm screw FDA UDI

Identifiers

Catalog Number: INS-9564 FDA UDI
Primary DI / UDI-DI: 06438408005336 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fluted surgical drill bit, 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: Fluted surgical drill bit, reusable

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

Similar devices

Also classified as Fluted surgical drill bit, reusable.

RingLoc® + — Biomet Orthopedics, Inc. · Class I
DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
MatrixMANDIBLE — Synthes · Class II
Brasseler — SUNCOAST DENTAL, INC. · Class I
ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
Straight Twist Drill — DENTIS CO. , LTD · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Inion , Ltd.

Sources (1)

FDA UDI 1cb4fb8b-b631-4f29-8e23-cb809d5717dc 34 fields · synced Jun 1, 2026