DEVICE: Match Point System (05420060366123)

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Device Record History
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Device Identifier (DI) Information
Match Point System
804-09-101
In Commercial Distribution
804-09-101
Materialise NV
05420060366123
GS1

1
373139427 *Terms of Use
Guide and Bone model for Total Shoulder Arthroplasty (AltiVate® Full Wedge)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62249 Custom-made organ/bone anatomy model/surgical guide kit
A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QHE Shoulder Arthroplasty Implantation System
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PHX Shoulder Prosthesis, Reverse Configuration
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K242813 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d5667344-cd40-4a7e-a02c-1144217fd67a
December 17, 2024
1
December 09, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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