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BKS Total PSI

FDA UDI

Class II (US FDA UDI)

by Materialise NV

Identity

Trade Name
BKS Total PSI FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
MRI Guides and Bone Models for Total Knee Arthroplasty FDA UDI
Model / Reference
KNM-OD01-00-01 FDA UDI
Description
MRI Guides and Bone Models for Total Knee Arthroplasty FDA UDI

Identifiers

Catalog Number
KNM-OD01-00-01 FDA UDI
Primary DI / UDI-DI
05420060360015 FDA UDI
510(k) Number
K221337 FDA UDI
FDA Product Code
JWH FDA UDI
MBH FDA UDI
OIY FDA UDI
OOG FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made organ/bone anatomy model/surgical guide kit

BKS Total PSI by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made organ/bone anatomy model/surgical guide kit.

Cleared under the same submission

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 df4717b9-1d18-42bd-8c41-4507354cc265 35 fields · synced Jun 1, 2026