510(k) K251315
- Device
- Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
- Applicant
- Remex Medical Corp.
- 510(k) number
- K251315
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-29
- Date received
- 2025-04-29
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cheng-Hsiung Wang
- Address
- 4f, #9, Jingke Rd., Nantun District Taichung TW 408209 408209
FDA Registration Numbers#
- 3004142400
- 3016050940
- 9617544
- 3005677016
- 3001239363
- 3008868758
- 3015869121
- 2024311
- 1221763
- 9611813
- 1423662
- 3010009693
- 3010313588
- 3003541440
- 3014252644
- 3009882675
- 3009381600
- 2244478
- 1000517406
- 3007728266
- 3014273424
- 1056553
- 3012764194
- 3010370554
- 3015877656
- 3026576110
- 3013917867
- 2031910
- 3005216725
- 1018470
- 1644408
- 3002807090
- 3006563559
- 3009973699
- 2031917
- 3010363503
- 3015941638
- 3019807891
- 3001592626
- 3009522766
- 3010986197
- 1226188
- 3005083075
- 3012911444
- 2031966
- 1721964
- 1424434
- 3014782362
- 3007997036
- 3014655115
- 3015399803
- 1834331
- 3003761012
- 2030624
- 3012227716
- 9614209
- 1625507
- 3007539489
- 3016678045
- 3003955307
- 3016619943
- 1835572
- 3015516266
- 3014725904
- 3013302242
- 3009973505
- 2219920
- 3001284227
- 1043653
- 3009973336
- 3005012805
- 3008027912
- 1000548922
- 3016261131
- 3010462278
- 3003678543
- 3010120326
- 3004608878
- 3010047454
- 3025343017
Source Documents#
Other 510(k) Records For Product Code OLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254158 | SPINEART Navigation Instrument System | Spineart SA | 2026-04-09 |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | 2026-03-27 |
| K260601 | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | 2026-03-26 |