MEDTECH SAS
Summary
- Total Recalls
- 5 (2 Class I)
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0118-2022 | Class I | ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation | September 22, 2021 |
| Z-1150-2020 | Class II | ROSA Brain 3.0 Application-Brain | January 6, 2020 |
| Z-1151-2020 | Class II | ROSA One 3.1 Brain Application | January 6, 2020 |
| Z-0172-2020 | Class I | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected | September 10, 2019 |
| Z-2108-2018 | Class II | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-contr | May 8, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231103 | ROSA ONE Brain Application | July 20, 2023 |
| K214065 | ROSA ONE Brain application | May 4, 2022 |
| K200511 | ROSA ONE Brain application | May 29, 2020 |
| K192173 | ROSA ONE Spine application | October 29, 2019 |
| K182848 | ROSA ONE Spine application | March 22, 2019 |
| K182417 | ROSA ONE Brain Application | February 7, 2019 |
| K172444 | ROSA BRAIN (v3.0.0.5) | March 28, 2018 |
| K151511 | ROSA Spine | January 4, 2016 |
| K151359 | ROSA Brain | December 18, 2015 |
| K101791 | ROSA SURGICAL DEVICE | September 23, 2010 |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | November 17, 2009 |
| K990663 | INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 | May 27, 1999 |