510(k) submissions
Filtered by Stereotactic Surgery · showing 51–68 of 68
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K230243 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-03-29 |
| K230180 | Rosa Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2023-02-22 |
| K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Spine Surgery | Medos International SARLSwitzerland | Stereotactic Surgery | Class 2 | 2023-01-19 |
| K223649 | VERTICALE® Navigation InstrumentsSpine Surgery | Silony Medical GmbHGermany | Stereotactic Surgery | Class 2 | 2022-12-22 |
| K222753 | SeaSpine 7D Navigation InstrumentsSpine Surgery | SeaSpine Orthopedics CorporationUnited States | Stereotactic Surgery | Class 2 | 2022-12-09 |
| K221928 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-10-04 |
| K222383 | Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) EditionSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Stereotactic Surgery | Class 2 | 2022-09-29 |
| K213873 | SkyWalker Total Knee SystemKnee Surgery | Microport Navibot International, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-07-07 |
| K220652 | Knee 3Knee Surgery | Brainlab AGGermany | Stereotactic Surgery | Class 2 | 2022-06-03 |
| K220973 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-06-01 |
| K213491 | Universal Pilot Guidance Instrument SystemSpine Surgery | Ctl Medical CorporationUnited States | Stereotactic Surgery | Class 2 | 2022-05-12 |
| K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetSpine Surgery | Medos International SARLSwitzerland | Stereotactic Surgery | Class 2 | 2022-05-05 |
| K213877 | ExactechGPS® SystemKnee Surgery | Blue OrthoFrance | Stereotactic Surgery | Class 2 | 2022-05-02 |
| K213708 | ROSA® Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-04-22 |
| K214011 | Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered DriversSpine Surgery | Medtronic Sofamor Danek USA, Inc.United States | Stereotactic Surgery | Class 2 | 2022-02-09 |
| K213918 | DeGen Navigated InstrumentationSpine Surgery | Degen MedicalUnited States | Stereotactic Surgery | Class 2 | 2022-02-09 |
| K214059 | CoreLink Navigation InstrumentsSpine Surgery | Corelink, LLCUnited States | Stereotactic Surgery | Class 2 | 2022-01-19 |
| K213033 | iASSIST Knee SystemKnee Surgery | Orthosoft Inc. (d/b/a) Zimmer CASCanada | Stereotactic Surgery | Class 2 | 2022-01-14 |