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CORUS Navigation Access System

FDA UDI

Class II (US FDA UDI)

by Providence Medical Technology, Inc.

Identity

Trade Name
CORUS Navigation Access System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation. FDA UDI
Model / Reference
DX-01-160 FDA UDI
Description
The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation. FDA UDI

Identifiers

Primary DI / UDI-DI
00852776006638 FDA UDI
510(k) Number
K240625 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Internal spinal fixation procedure kit, single-use

CORUS Navigation Access System by Providence Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Providence Medical Technology, Inc.

Sources (1)

  • FDA UDI 0abf6e04-5f82-4396-b0ab-9bde27901ecf 34 fields · synced Jun 1, 2026