BKS Total PSI KNM-OD01-00-01

GUDID 05420060360015

MRI Guides and Bone Models for Total Knee Arthroplasty

Materialise NV

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

Primary Device ID	05420060360015
NIH Device Record Key	df4717b9-1d18-42bd-8c41-4507354cc265
Commercial Distribution Status	In Commercial Distribution
Brand Name	BKS Total PSI
Version Model Number	KNM-OD01-00-01
Catalog Number	KNM-OD01-00-01
Company DUNS	373139427
Company Name	Materialise NV
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05420060360015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221337

FDA Product Code

JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer