510(k) K193560
- Device
- Materialise Shoulder Guide And Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
- Applicant
- Materialise NV
- 510(k) number
- K193560
- Product code
- QHE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-20
- Date received
- 2019-12-23
- 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
- No
Applicant Contact#
- Contact
- Veerle Vanderheyden
- Address
- Technologielaan 15 Leuven BE 3001 3001
FDA Registration Numbers#
- 3031914485
- 3016851379
- 1220246
- 3002579136
- 3014027736
- 9617840
- 3011724582
- 3006721341
- 3005718816
- 3014004349
- 3004983210
- 3000931034
- 3008110533
- 2249608
- 3015231789
- 3012470322
- 3007841013
- 3009555440
- 3006990600
- 3009555447
- 3010236732
- 3005180920
- 3008388276
- 3015806723
- 3020704423
- 3014262693
- 3003998208
- 1064858
- 3003018722
- 3010331645
- 1822565
- 1043534
- 3014833750
- 1649390
- 3013561205
Source Documents#
Other 510(k) Records For Product Code QHE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260104 | Signature™ ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 |
| 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 |
| K231112 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2023-09-12 |
| 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 |
Legacy Summary#
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FDA Review#
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