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#
- 1935627
- 3007728266
- 3018405359
- 1319639
- 3017565094
- 3008812560
- 3025783933
- 3010408671
- 3011713200
- 3007993775
- 2031910
- 3005075696
- 3005739886
- 3004024955
- 1835572
- 3020375573
- 3005180920
- 9616696
- 1424434
- 3016438694
- 3015941638
- 3012764194
- 3014680149
- 2133810
- 9680515
- 3030400539
- 3005819474
- 3010663372
- 2081135
- 3007922509
- 3015907115
- 9611827
- 3010120135
- 3003678543
- 3003596442
- 3008868758
- 8031020
- 3004060780
- 3014252644
- 1828288
- 3013485140
- 3009165919
- 1834331
- 3007485169
- 3010041499
- 1057425
- 3043543260
- 3021902355
- 3009185973
- 3005677016
- 2133928
- 3016084569
- 1824199
- 3009962553
- 3008455034
- 3016496998
- 3008114965
- 1649518
- 3010009693
- 3012447612
- 3012120772
- 3005012805
- 2648623
- 3009417901
- 3009293341
- 3010173425
- 9611813
- 3009337690
- 3005874553
- 3006984710
- 3010822102
- 3004976965
- 3017823294
- 3007700286
- 3002907620
- 9612420
- 3010120104
- 3003500271
- 3009266751
- 3004638600
Source Documents#
Other 510(k) Records For Product Code OLO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026-06-02 |
Legacy Summary#
summary