AtlasPlan SHC-IN03-01-01

GUDID 05420060367076

Guide for Reverse Shoulder Arthroplasty Aetos

Materialise NV

Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model

Primary Device ID	05420060367076
NIH Device Record Key	cc63c9cd-2ed3-4e1b-a90f-7d4453a14b83
Commercial Distribution Status	In Commercial Distribution
Brand Name	AtlasPlan
Version Model Number	SHC-IN03-01-01
Catalog Number	SHC-IN03-01-01
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	05420060367076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K233408

FDA Product Code

KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented