Navigated Anterolateral Disc Prep Instruments

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Navigated Anterolateral Disc Prep Instruments FDA UDI
Generic Name: Orthopaedic surgical distractor, internal FDA UDI
Device Name: DISTRACTOR NAV4680018 NAV DISTRACTOR 4MM FDA UDI
Model / Reference: NAV4680018 FDA UDI
Description: DISTRACTOR NAV4680018 NAV DISTRACTOR 4MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000200879 FDA UDI
510(k) Number: K192336 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Orthopaedic surgical distractor, internal 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

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 — 4.0 Millimeter FDA UDI

Category: Orthopaedic surgical distractor, internal

Navigated Anterolateral Disc Prep Instruments by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192336 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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI c88a0ab8-6b1d-4a43-b9b2-bb56f3b9bc57 36 fields · synced May 30, 2026