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Spinemap

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
SPINEMAP FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
SPINEMAP¿ 3D 3.1 - SALES DEMO FDA UDI
Model / Reference
81-81039 FDA UDI
Description
SPINEMAP¿ 3D 3.1 - SALES DEMO FDA UDI

Identifiers

Catalog Number
81-81039 FDA UDI
Primary DI / UDI-DI
07613327359961 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Surgical planning/navigation-enhancement 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

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: Surgical planning/navigation-enhancement system

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

Similar devices

Also classified as Surgical planning/navigation-enhancement 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 c14ac171-b91b-44b1-a849-41ba16837982 34 fields · synced May 31, 2026