FDA Product Code
FDA Product Code QHE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3660
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2026-06-09 | Traditional | PDF ↗ |
| K261510 | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-06-04 | Special | PDF ↗ |
| K260104 | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-02-04 | Special | PDF ↗ |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2026-01-12 | Traditional | PDF ↗ |
| K243509 | Archer PSI System | 3D-Side | 2025-05-12 | Traditional | PDF ↗ |
| K241470 | CORE Shoulder System | LinkBio Corp. | 2025-02-20 | Traditional | PDF ↗ |
| K243955 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2025-01-21 | Special | PDF ↗ |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2024-10-18 | Special | PDF ↗ |
| K241097 | Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. | 2024-10-02 | Traditional | PDF ↗ |
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | 2024-08-05 | Traditional | PDF ↗ |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2024-05-22 | Special | PDF ↗ |
| K232425 | Signature ONE System | Orthosoft Inc. (D/B/A) Zimmer Cas) | 2023-12-12 | Traditional | PDF ↗ |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2023-11-09 | Special | PDF ↗ |
| K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2023-09-12 | Traditional | PDF ↗ |
| K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-06-22 | Traditional | PDF ↗ |
| K222007 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex, Inc. | 2023-03-08 | Traditional | PDF ↗ |
| K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | 2023-03-06 | Special | PDF ↗ |
| K222405 | Smart SPACE Shoulder Planner and 3D Positioners | Lima Corporate S.P.A. | 2022-12-20 | Traditional | PDF ↗ |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | Materialise NV | 2022-08-17 | Traditional | PDF ↗ |
| K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV | 2022-01-12 | Traditional | PDF ↗ |
| K212560 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2021-10-12 | Traditional | PDF ↗ |
| K202151 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2021-02-03 | Traditional | PDF ↗ |
| K202454 | Smart SPACE Shoulder System | Techmah Medical, LLC | 2020-12-28 | Traditional | PDF ↗ |
| K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2020-06-05 | Traditional | PDF ↗ |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | Materialise NV | 2020-03-20 | Traditional | PDF ↗ |
| K192074 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-08-30 | Special | PDF ↗ |
Product code QHE · Class II · Orthopedic. Data: openFDA.