510(k) K231112
- Device
- Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Applicant
- Materialise NV
- 510(k) number
- K231112
- Product code
- QHE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-12
- Date received
- 2023-04-19
- Regulation
- 888.3660
- Classification name
- Shoulder Arthroplasty Implantation System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Giulia Girola
- Address
- Technologielaan 15 Leuven BE 3001 3001
FDA Registration Numbers
- 3005180920
- 3031914485
- 9617840
- 1649390
- 3005718816
- 3014262693
- 3003018722
- 3009555440
- 1043534
- 3008388276
- 3010331645
- 3010236732
- 1220246
- 3009555447
- 3008110533
- 3011724582
- 3006990600
- 3020704423
- 3015231789
- 1822565
- 3006721341
- 3013561205
- 3014027736
- 3002579136
- 3015806723
- 3012470322
- 3000931034
- 3007841013
- 3016851379
- 3003998208
- 3004983210
- 3014004349
- 2249608
- 1064858
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code QHE
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|---|---|---|---|
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| K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026-01-12 |
| K243509 | Archer PSI System | 3D-Side | 2025-05-12 |
| K241470 | CORE Shoulder System | LinkBio Corp. | 2025-02-20 |
| K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025-01-21 |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2024-10-18 |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024-10-02 |
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024-08-05 |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2024-05-22 |
| K232425 | Signature ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2023-11-09 |
| K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-06-22 |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-03-08 |
| K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | 2023-03-06 |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022-12-20 |