510(k) K251943
- Device
- Spineology Navigation Instruments
- Applicant
- Spineology, Inc.
- 510(k) number
- K251943
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-04
- Date received
- 2025-06-24
- 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
- Megan Polos
- Address
- 7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128
FDA Registration Numbers#
- 3003678543
- 3014725904
- 3003541440
- 3009433026
- 1020279
- 3009973699
- 3010041430
- 9616696
- 3005083075
- 3003596442
- 2030624
- 3009959868
- 3014782362
- 3003637761
- 3006783837
- 3012495575
- 3006654680
- 3041276509
- 2249615
- 3011713200
- 3004142400
- 1221763
- 3002807090
- 2531477
- 3004153896
- 9680515
- 1526439
- 3011187779
- 3013485140
- 3014273424
- 3017980495
- 3010822102
- 3010032903
- 1043653
- 2027467
- 1720929
- 3005739886
- 1644408
- 3005874553
- 3037407500
- 1828464
- 1833506
- 1123169
- 3017123055
- 3004774118
- 3005012805
- 3010531060
- 3012428435
- 3007125392
- 9617544
- 1818910
- 3006984710
- 3005216725
- 3018405359
- 1835444
- 3020703621
- 3010863450
- 2530808
- 3012966183
- 3015941638
- 3024788684
- 3021632375
- 3009266751
- 3033536255
- 3017406274
- 3010129044
- 3004727093
- 3007539489
- 3001239363
- 3001284227
- 3008837339
- 1836357
- 2528981
- 3010462278
- 3011796723
- 3014170143
- 3003139373
- 2081135
- 3013422238
Source Documents#
Other 510(k) Records For Product Code OLO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |