Navigated Infinity ™ Instruments

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Navigated Infinity ™ Instruments FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: DRILL NAVNS3606010 2.4MM NAV NONSTERILE FDA UDI
Model / Reference: NAVNS3606010 FDA UDI
Description: DRILL NAVNS3606010 2.4MM NAV NONSTERILE FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169862494 FDA UDI
510(k) Number: K173338 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

Category: Fluted surgical drill bit, reusable

Navigated Infinity ™ Instruments by Medtronic Sofamor Danek, Inc. — Class II — 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

Cleared under the same submission

K173338 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

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

Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI e9676f41-8ed9-4103-9474-fe2d4d88bafa 35 fields · synced Jun 1, 2026