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Orthomap

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
ORTHOMAP FDA UDI
Generic Name
Robotic surgical navigation system application software FDA UDI
Device Name
ORTHOMAP¿ 3D 2.0 - ENABLE FDA UDI
Model / Reference
6005-660-300 FDA UDI
Description
ORTHOMAP¿ 3D 2.0 - ENABLE FDA UDI

Identifiers

Catalog Number
6005-660-300 FDA UDI
Primary DI / UDI-DI
07613252127413 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Robotic surgical navigation system application software 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Robotic surgical navigation system application software

Orthomap by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical navigation system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 9afce4a3-1174-496a-a125-f8d1aed45b84 34 fields · synced May 30, 2026