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#
- 3005497913
- 8043933
- 3010047454
- 3006639944
- 1226544
- 1833986
- 3007344102
- 3006783837
- 3014479313
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- 3019767615
- 3003477135
- 3004893332
- 3015536273
- 3009293341
- 3012447612
- 3016084569
- 3019878714
- 3040312029
- 2528981
- 3009971621
- 3004727093
- 2219920
- 3017565094
- 3038503932
- 3018094310
- 3011015572
- 3010141593
- 3007700286
- 3012263546
- 3001239363
- 3003525643
- 2133641
- 3007441485
- 3011683674
- 3010123206
- 3008583793
- 1225492
- 3010129044
- 3008992889
- 1720929
- 1835296
- 3003541440
- 9616696
- 3006791286
- 3010370554
- 3004142400
- 9614209
- 3017823294
- 1423662
- 3012966183
- 3009887475
- 3010531060
- 3006128100
- 3007366790
- 1319660
- 1828464
- 3006460162
- 2133772
- 3007997036
- 3010120104
- 3016438694
- 3030400539
- 3010663372
- 1218017
- 3043520111
- 3010197239
- 3014411622
- 9617544
- 9617297
- 3013404959
- 3036756245
- 3010049501
- 3009380063
- 1064858
- 9612420
- 3014252644
Source Documents#
Other 510(k) Records For Product Code OLO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary