Glenoid Reconstruction System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- GRS baseplate - Ø27x30 +6mm EUDAMEDGlenoid Reconstruction System FDA UDI
- Generic Name
- Reverse shoulder prosthesis base plate FDA UDI
- Device Name
- GRS baseplate - Ø27x30 +6mm FDA UDI
- Model / Reference
- 04.01.0311 EUDAMEDFDA UDIShoulder Baseplate RSA – Ti+HA coating EUDAMED
- Description
- GRS baseplate - Ø27x30 +6mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345710406 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07630345710406 EUDAMED
- 510(k) Number
- K213459 FDA UDI
- FDA Product Code
- PHX FDA UDI
- EMDN Code
- P09010301 METAL BACK AND METAGLENE GLENOID BASEPLATES EUDAMED
- GMDN Term
- Reverse shoulder prosthesis base plate FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Reverse shoulder prosthesis base plate
Glenoid Reconstruction System by Medacta International — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder prosthesis base plate.
- AGILON® XO glenoid cementless cpTi — implantcast GmbH · Class II
- Titan™ — Ascension Orthopedics, Inc. · Class II
- AEQUALIS™ PerFORM+ Reversed — TORNIER, INC. · Class II
- Tornier Perform® Reversed Augmented Glenoid — TORNIER, INC. · Class II
- REUNION — Stryker Corp. · Class II
- Delta Xtend — DEPUY (IRELAND) · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
Cleared under the same submission
K213459 also covers:
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
- Glenoid Reconstruction System — Medacta International
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI d021f29a-f47c-4d11-a672-d1ea33fdf8be 34 fields · synced Jul 27, 2026
- EUDAMED 264c4a78-7fbf-476d-827a-f2ea109f0f87 61 fields · synced Jul 27, 2026