Navigation Instrument tray

FDA UDI

Class II (US FDA UDI)

by Ecential Robotics

Identity

Trade Name: Navigation Instrument tray FDA UDI
Generic Name: Surgical instrument/implant rack FDA UDI
Model / Reference: A00067 FDA UDI

Identifiers

Primary DI / UDI-DI: 03701311500902 FDA UDI
510(k) Number: K242914 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Surgical instrument/implant rack 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

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

Dry Heat Sterilization FDA UDI

Category: Surgical instrument/implant rack

Navigation Instrument tray by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/implant rack.

MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class I
VASSOIO GAMMAFIX DOI ROSA — MEDESY srl · Class I
LOQTEQ® — aap Implantate AG · Class I
1208 — Siam intermagnate CO.,LTD. · Class I
VASSOIO GAMMAFIX CINC AZZURRO — MEDESY srl · Class I
Accessories, arthroscopic — PARCUS MEDICAL LLC · Class I
SPIRECUT — Spirecut AG · Class I
MATRIXWAVE — Synthes · Class I

Cleared under the same submission

K242914 also covers:

Op.n Camera — ECENTIAL ROBOTICS
Op.n ChoiceSpine App — ECENTIAL ROBOTICS
Op.n Core — ECENTIAL ROBOTICS
Op.n Perla TL Nav Software — ECENTIAL ROBOTICS
Op.n Tracker A — ECENTIAL ROBOTICS
Op.n Tracker B — ECENTIAL ROBOTICS
Op.n Tracker C — ECENTIAL ROBOTICS
Op.n Tracker D — ECENTIAL ROBOTICS
Tracker fixation screw — ECENTIAL ROBOTICS

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: Ecential Robotics

Sources (1)

FDA UDI 3c16cd1c-f09e-4ab6-9c75-090132af26fd 33 fields · synced May 30, 2026