510(k) submissions
Filtered by Unclassified · showing 1–17 of 17
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CASCanada | — | Class 2 | 2026-05-21 |
| K242933 | SPINEART Navigation Instrument System | Spineart SASwitzerland | — | Class 2 | 2025-06-18 |
| K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics CorporationUnited States | — | Class 2 | 2025-04-02 |
| K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc.United States | — | Class 2 | 2025-03-14 |
| K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CASCanada | — | Class 2 | 2024-10-18 |
| K233706 | Bendini Cloud Application | NuvasiveUnited States | — | Class 2 | 2024-08-02 |
| K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc.United States | — | Class 2 | 2024-04-29 |
| K232345 | ATEC Posterior Navigated Disc Prep Instruments | Alphatec Spine, Inc.United States | — | Class 2 | 2023-11-02 |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AGUnited States | — | Class 2 | 2023-08-02 |
| K222510 | Blueprint Mixed Reality system | Tornier S.A.S.France | — | Class 2 | 2023-01-20 |
| K220774 | RobPath® Total Hip Application | Hangzhou Lancet Robotics Co., Ltd.China | — | Class 2 | 2022-12-09 |
| K220241 | “POINT” Kinguide Robotic-Assisted Surgical System | Point Robotics MedTech, Inc.Taiwan | — | Class 2 | 2022-08-09 |
| K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V | Remex Medical Corp.Taiwan | — | Class 2 | 2022-07-14 |
| K220146 | VisAR | Novarad CorporationUnited States | — | Class 2 | 2022-05-27 |
| K220038 | Camber Spine Navigation System | Camber Spine TechnologiesUnited States | — | Class 2 | 2022-04-29 |
| K220459 | Mako Total Knee Application | Mako Surgical Corp.United States | — | Class 2 | 2022-04-15 |
| K220255 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc.United States | — | Class 2 | 2022-03-29 |