Match Point System 804-03-057

GUDID E31480403057

Patient specific instrumentation for shoulder arthroplasty

Materialise NV

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

• Primary Device ID: E31480403057
• NIH Device Record Key: 81948498-7894-40f1-9bbe-198eaf277237
• Commercial Distribution Discontinuation: 2017-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Match Point System
• Version Model Number: 804-03-057
• Catalog Number: 804-03-057
• 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: true
• 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	E31480403057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153602

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

[E31480403057]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-24

On-Brand Devices [Match Point System]

• E314804251480: Patient specific instrumentation for shoulder arthroplasty
• E31480425148: Patient specific instrumentation for shoulder arthroplasty
• E314804070220: Patient specific instrumentation for shoulder arthroplasty
• E314804030580: Patient specific instrumentation for shoulder arthroplasty
• E31480403058: Patient specific instrumentation for shoulder arthroplasty
• E314804030570: Patient specific instrumentation for shoulder arthroplasty
• E31480403057: Patient specific instrumentation for shoulder arthroplasty
• 05420060366123: Guide and Bone model for Total Shoulder Arthroplasty (AltiVate® Full Wedge)
• 05420060366116: Guide and Bone model for Reverse Shoulder Arthroplasty (AltiVate® Reverse)