510(k) K183196
- Device
- Stryker Navigation System With SpineMap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, SpineMask Tracker
- Applicant
- Stryker Corporation
- 510(k) number
- K183196
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-14
- Date received
- 2018-11-19
- Regulation
- 882.4560
- Classification name
- Orthopedic Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Andrea Wallen-Gerding
- Address
- Boetzinger Strasse 41 Freiburg DE D-79111 D-79111
FDA Registration Numbers#
- 3009051471
- 3004499989
- 8043933
- 3010197239
- 1526534
- 3010197224
- 3005075696
- 9614209
- 3010120339
- 3005641619
- 2183449
- 9611390
- 3011674645
- 3004635447
- 3016090213
- 3015877656
- 9611112
- 3013485140
- 3008114965
- 3010155648
- 3006654680
- 1226188
- 3010129044
- 3012429289
- 3005751028
- 3021902355
- 3014411622
- 3017528621
- 3011656326
- 9617297
- 2530808
- 3017123055
- 9610622
- 3021008900
- 3038503932
- 3010232390
- 3011782009
- 3025343017
- 3043520111
- 3004016520
- 1828288
- 3012966183
- 3002907620
- 3010123206
- 3009144915
- 3007366790
- 3004142400
- 1123169
- 3016084569
- 1045834
- 3016619943
- 3023852420
- 3009266751
- 8031020
- 3010120148
- 3039520898
- 1030489
- 3010173425
- 3009971621
- 3017565094
- 1319660
- 3013422238
- 3025110439
- 1721964
- 3009887475
- 3006563559
- 3010120104
- 3017406274
- 2133786
- 3006846753
- 3009959868
- 3009293341
- 3017492965
- 3001592626
- 1043653
- 1935627
- 3010162973
- 1834331
- 3009394448
- 3036756245
Source Documents#
Other 510(k) Records For Product Code OLO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary