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#
- 3027153110
- 9617297
- 1226544
- 2027487
- 3009493875
- 3010047402
- 3007993775
- 3007485169
- 1314417
- 3010009632
- 3003139373
- 3006846753
- 3009554293
- 3009871135
- 3005819474
- 3006563559
- 3004727093
- 3015869121
- 3043543260
- 3026576110
- 2531477
- 3036756245
- 3008027912
- 3034676720
- 1218017
- 3006654680
- 3010039400
- 1828288
- 3015941638
- 3014680149
- 3005751028
- 3001284227
- 3024999441
- 3010822102
- 1421101
- 3016443334
- 3010120326
- 3004893332
- 3021902355
- 2530808
- 3010408671
- 2030624
- 2133786
- 3016075969
- 3012263546
- 3018405359
- 3010120135
- 3008110533
- 3010363503
- 3017565094
- 1047843
- 3014252644
- 1219602
- 3004181214
- 3014498598
- 1064858
- 1526439
- 3009394448
- 3006125668
- 3012495575
- 3011713200
- 1221763
- 3004774118
- 9616696
- 3003604053
- 3010041430
- 1424263
- 9617840
- 9680515
- 3003637761
- 2219920
- 3016261131
- 3015516266
- 3013552417
- 3002807090
- 3003935342
- 8010177
- 3003596442
- 3017123055
- 3024788684
Source Documents#
Other 510(k) Records For Product Code OLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260403 | 7D Surgical System (10-0001) | 7D Surgical ULC | 2026-10-19 |
| K263234 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026-10-16 |
| K263154 | CarboClear® Cervical Navigated Instruments | CarboFix Orhtopedics , Ltd. | 2026-10-09 |
| K262257 | Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine | Brainlab SE | 2026-09-30 |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026-08-20 |
| 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 |