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#
- 3020703621
- 3008583793
- 3006791286
- 3011577940
- 3010141593
- 3004464325
- 3030154790
- 3007125392
- 3010097171
- 1045834
- 3010032903
- 3007366790
- 3010120104
- 3011015572
- 3010370554
- 3021008900
- 3041276509
- 3010232390
- 2031910
- 3003639920
- 3009887475
- 3007441485
- 3007344102
- 3010120148
- 2011171
- 1423662
- 3011656326
- 2133928
- 3016075969
- 3009882675
- 3018565653
- 3006128100
- 1319660
- 3009973699
- 3037407500
- 1928237
- 2031093
- 3008455034
- 3005677016
- 3004016520
- 9611813
- 3009293341
- 3009185973
- 3014725904
- 3002807090
- 3010120339
- 3005751028
- 2528981
- 3005180920
- 3012911444
- 8010177
- 1218017
- 9611390
- 3009962553
- 3009165919
- 3005823819
- 3010057495
- 3007700286
- 3011796723
- 3009417901
- 3004126422
- 3004060780
- 3025783933
- 3015941638
- 3017528621
- 3018094310
- 3013194153
- 3009394448
- 3003139373
- 3010313588
- 3010531060
- 3003500271
- 3006776201
- 1835296
- 3014170143
- 3010363503
- 3012764194
- 3016438694
- 3003604053
- 3006493760
Source Documents#
Other 510(k) Records For Product Code OLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | 2026-07-30 |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | 2026-07-29 |
| 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 |