Match Point System 804-07-022

GUDID E314804070220

Patient specific instrumentation for shoulder 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 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	E314804070220
NIH Device Record Key	56895cc0-cb77-4868-b42d-0f37f8f8fa66
Commercial Distribution Status	In Commercial Distribution
Brand Name	Match Point System
Version Model Number	804-07-022
Catalog Number	804-07-022
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
HIBCC	E314804070220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170893

FDA Product Code

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