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Spinemask

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
SPINEMASK FDA UDI
Generic Name
Optical surgical navigation device tracking system FDA UDI
Device Name
SPINEMASK (TM) TRACKER FDA UDI
Model / Reference
6002-390-000 FDA UDI
Description
SPINEMASK (TM) TRACKER FDA UDI

Identifiers

Catalog Number
6002-390-000 FDA UDI
Primary DI / UDI-DI
37613252731437 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Optical surgical navigation device tracking system 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 25.0 Millimeter FDA UDI
Width — 255.0 Millimeter FDA UDI
Length — 377.0 Millimeter FDA UDI

Category: Optical surgical navigation device tracking system

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

Similar devices

Also classified as Optical surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI fe333605-6c58-40f7-9fe4-44889025f238 36 fields · synced May 30, 2026