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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 Knee Planner FDA UDI
Model / Reference
SurgiCase Knee Planner FDA UDI
Description
SurgiCase Knee Planner FDA UDI

Identifiers

Catalog Number
SurgiCase Knee Planner FDA UDI
Primary DI / UDI-DI
05404028000922 FDA UDI
510(k) Number
K150928 FDA UDI
K162273 FDA UDI
K172650 FDA UDI
K173445 FDA UDI
K173970 FDA UDI
K202207 FDA UDI
K221337 FDA UDI
K251554 FDA UDI
FDA Product Code
OOG FDA UDI
OIY FDA UDI
MBH FDA UDI
JWH FDA UDI
HSX 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
888.3520 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: CAD/CAM software

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

Similar devices

Also classified as CAD/CAM software.

Cleared under the same submission

K150928 also covers:

K162273 also covers:

K172650 also covers:

K173445 also covers:

K173970 also covers:

K202207 also covers:

K221337 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA UDI c29e0939-b543-4e9e-b0bb-497b85b4d1d5 35 fields · synced Jun 6, 2026