FDA 510(k) Applications for Medical Device Product Code "QHE"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243509 | 3D-Side | Archer PSI System | 05/12/2025 |
| K222007 | Arthrex Inc. | Arthrex Virtual Implant Positioning (VIP) System | 03/08/2023 |
| K230904 | Arthrex Inc. | Arthrex Virtual Implant Positioning (VIP) System | 06/22/2023 |
| K241097 | Arthrex, Inc. | Arthrex Virtual Implant Positioning (VIP) System Software | 10/02/2024 |
| K222405 | LimaCorporate S.p.A | Smart SPACE Shoulder Planner and 3D Positioners | 12/20/2022 |
| K241470 | LinkBio Corp. | CORE Shoulder System | 02/20/2025 |
| K233408 | Materialise N.V. | Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | 11/09/2023 |
| K241143 | Materialise N.V. | Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | 05/22/2024 |
| K242813 | Materialise N.V. | Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | 10/18/2024 |
| K193560 | Materialise NV | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | 03/20/2020 |
| K230315 | Materialise NV | Materialise Shoulder SystemÖ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | 03/06/2023 |
| K212569 | Materialise NV | Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | 01/12/2022 |
| K231112 | Materialise NV | Materialise Shoulder SystemÖ, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | 09/12/2023 |
| K220452 | Materialise NV | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | 08/17/2022 |
| K200615 | Orthosoft Inc. (d/b/a Zimmer CAS) | Signature ONE System | 06/05/2020 |
| K212560 | Orthosoft Inc. (d/b/a Zimmer CAS) | SignatureÖ ONE System | 10/12/2021 |
| K232425 | Orthosoft Inc. (d/b/a) Zimmer CAS) | SignatureÖ ONE System | 12/12/2023 |
| K192074 | Orthosoft, Inc. (d/b/a Zimmer CAS) | Signature ONE System | 08/30/2019 |
| K243955 | Precision AI Pty Ltd | Precision AI Surgical Planning System (PAI-SPS) | 01/21/2025 |
| K233992 | Precision AI Pty Ltd | Precision AI Surgical Planning System (PAI-SPS) | 08/05/2024 |
| K202151 | TechMah Medical LLC | Smart SPACE Shoulder System | 02/03/2021 |
| K202454 | TechMah Medical LLC | Smart SPACE Shoulder System | 12/28/2020 |
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