METRx® System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: METRx® System FDA UDI
Generic Name: Endoscope camera adaptor FDA UDI
Device Name: INSTRUMENT 9560107 3 CHIP CAM ADPTR FDA UDI
Model / Reference: 9560107 FDA UDI
Description: INSTRUMENT 9560107 3 CHIP CAM ADPTR FDA UDI

Identifiers

Primary DI / UDI-DI: 00673978085524 FDA UDI
510(k) Number: K993021 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Endoscope camera adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 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

Category: Endoscope camera adaptor

METRx® System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope camera adaptor.

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JEDMED — JEDMED Instrument Company · Class II
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Fibre optic cable adpater — JOIMAX, INC. · Class I
Aspen® O.R. Camera Cover Adapter — Aspen Surgical Products, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
RIWO — Richard Wolf GmbH · Class II

Cleared under the same submission

K993021 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 c00d7ff7-5e44-46dc-8728-aae15eb6c1fb 35 fields · synced Jun 1, 2026