510(k) K231527
- Device
- TriALTIS Navigation Enabled Instruments
- Applicant
- Medos International Sàrl
- 510(k) number
- K231527
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-29
- Date received
- 2023-05-26
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nicole Aeschbacher
- Address
- Chemin-Blanc 38 Le Locle CH 2400 2400
FDA Registration Numbers#
- 3000719653
- 1833920
- 3009185973
- 3015941638
- 1000517406
- 3009493875
- 3010047402
- 3004513872
- 1047843
- 3018405359
- 3012495575
- 1226544
- 3009417901
- 3005874553
- 3013917867
- 3016084569
- 1319639
- 1221053
- 3038503932
- 3012639025
- 3006654680
- 3026776
- 3009380063
- 3010162973
- 1723170
- 3021060474
- 1835251
- 3007014520
- 3009337690
- 9680515
- 3025343017
- 3006791286
- 3005216725
- 2249615
- 2133641
- 3006984710
- 3009882675
- 3010120326
- 3013404959
- 3017492965
- 3037407500
- 9611579
- 3004499989
- 3002743211
- 3016261131
- 1824199
- 3025603301
- 3007485169
- 3014479313
- 3012764194
- 2024311
- 3010120148
- 3012227716
- 3008837339
- 3007922509
- 1834331
- 1218017
- 9611390
- 3006125668
- 3009293341
- 3005497913
- 1828464
- 3019878714
- 3015537048
- 1928237
- 3018094310
- 3010155648
- 1625507
- 2031966
- 9617297
- 3004142400
- 3009433026
- 3009971621
- 1720929
- 3010041430
- 3010032903
- 3010009693
- 3011577940
- 3016619943
- 1833824
Source Documents#
Other 510(k) Records For Product Code OLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-07-24 |
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | 2026-07-24 |
| K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026-07-22 |
| K261852 | OTS Hip | Ortoma AB | 2026-07-01 |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | 2026-06-26 |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | 2026-06-25 |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | 2026-06-20 |
| K261665 | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | 2026-06-18 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026-06-02 |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | 2026-05-29 |
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026-05-26 |
| K260329 | Ion-C Navigation Instruments | SurGenTec, LLC | 2026-05-22 |
| K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026-05-21 |
| K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | 2026-05-11 |
| K260011 | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | 2026-04-16 |