SurgiCase Planner

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name: SurgiCase Planner FDA UDI
Generic Name: CAD/CAM software FDA UDI
Device Name: SurgiCase Planner FDA UDI
Model / Reference: SurgiCase Planner FDA UDI
Description: SurgiCase Planner FDA UDI

Identifiers

Catalog Number: SurgiCase Planner FDA UDI
Primary DI / UDI-DI: E314SURGICASEPLANNER0 FDA UDI
510(k) Number: K150928 FDA UDI
K153602 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
OIY FDA UDI
OOG FDA UDI
KWS FDA UDI
GMDN Term: CAD/CAM software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 FDA UDI
888.3660 FDA UDI
Commercial Distribution: Not 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

SurgiCase Planner by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K150928 also covers:

K153602 also covers:

Lima PSI — Materialise NV

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: Materialise NV

Sources (1)

FDA UDI d38de10d-d11c-43a7-b426-e20d2273a4c5 36 fields · synced May 31, 2026