510(k) K252989
- Device
- POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set
- Applicant
- Point Robotics MedTech, Inc.
- 510(k) number
- K252989
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-20
- Date received
- 2025-09-18
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Wayne Kao
- Address
- 7f, #219, Sec.3 Beixin Rd., Xindian Dist. New Taipei City TW 231 231
FDA Registration Numbers
- 1450662
- 3013917867
- 3033536255
- 3009394448
- 3014782362
- 3004464325
- 3014252644
- 2031917
- 3001239363
- 1421101
- 3023852420
- 1834331
- 3003541440
- 3025783933
- 3014411622
- 3013194153
- 3009962553
- 1833824
- 3018405359
- 2031093
- 1045834
- 1643264
- 3016090213
- 3003637761
- 3009293341
- 1319660
- 9611579
- 3003678543
- 1625507
- 1064858
- 3007700286
- 3012429289
- 9612277
- 8010177
- 3004126422
- 3010863450
- 3019767615
- 3013682146
- 3017492965
- 3006128100
- 8043933
- 1030489
- 3004719693
- 2183449
- 1723170
- 3013485140
- 3004024955
- 3013552417
- 3012120772
- 3005751028
- 3002743211
- 3006125668
- 3005083075
- 3009887475
- 2081135
- 1221053
- 3010047454
- 3043520111
- 3009973505
- 3009554293
- 2087234
- 3006776201
- 3012447612
- 1721964
- 9611827
- 9610622
- 3007515069
- 1835296
- 1314417
- 3020375573
- 9615128
- 3008992889
- 3010531060
- 2024311
- 3003604053
- 3004893332
- 1833986
- 3015907115
- 3025343017
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code OLO
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | 2026-03-25 |
| K253604 | TiLink-L Navigation Instruments | SurGenTec, LLC | 2026-03-20 |
| K253444 | EUROPA Posterior Cervical Fusion Navigated Instruments | MiRus, LLC | 2026-03-18 |
| K260546 | Q Pedicle Instruments | K2m, Inc. | 2026-03-17 |
| K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026-03-03 |
| K260222 | Mako Total Knee Application | Mako Surgical Corp. | 2026-02-25 |
| K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. | 2026-02-19 |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG | 2026-02-19 |
| K254148 | VERTICALE GPS Instruments | Silony Medical GmbH | 2026-02-19 |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | 2026-02-12 |