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: Bone lever/elevator, reusable FDA UDI
Device Name: COBB NAV4680007 NAV OBL/ANGLE COBB 20MM FDA UDI
Model / Reference: NAV4680007 FDA UDI
Description: COBB NAV4680007 NAV OBL/ANGLE COBB 20MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000200800 FDA UDI
510(k) Number: K192336 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Bone lever/elevator, 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

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 — 20.0 Millimeter FDA UDI

Category: Bone lever/elevator, reusable

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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Also classified as Bone lever/elevator, reusable.

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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 74978f25-ed4b-4942-9661-31938a15af4a 36 fields · synced Jun 7, 2026