510(k) K251971
- Device
- RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
- Applicant
- Stryker Instruments
- 510(k) number
- K251971
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-25
- Date received
- 2025-06-26
- 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
- No
Applicant Contact#
- Contact
- Susanne Galin
- Address
- 1941 Stryker Way Portage MI US 49002 49002
FDA Registration Numbers#
- 3010097171
- 1226188
- 3001239363
- 1424263
- 3003596442
- 3004060780
- 3040335671
- 3011577940
- 9617840
- 3007014520
- 3010408671
- 3014498598
- 3018405359
- 9614209
- 3004209178
- 3012495575
- 3007344102
- 3016261131
- 3006563559
- 3009144915
- 3005216725
- 1833920
- 3010057495
- 1319660
- 1835296
- 3011187779
- 3026776
- 3004126422
- 3015542154
- 3007700286
- 3007997036
- 3014170143
- 1835572
- 3009879967
- 1319639
- 2246552
- 3005819474
- 1000517406
- 2090010
- 3008837339
- 3009887475
- 3015907115
- 3006125668
- 3009051471
- 1833986
- 3010049501
- 3009888740
- 3009165919
- 2030624
- 1928237
- 3010462278
- 3011015572
- 3008455034
- 3003500271
- 3004976965
- 3006639944
- 3008110533
- 1720929
- 3003678543
- 3010120339
- 1064858
- 9611813
- 3010663372
- 1828288
- 3012227716
- 3039520898
- 2648623
- 3010986197
- 3034676720
- 1020279
- 8043792
- 1226544
- 9612277
- 3003617485
- 1644408
- 3025343017
- 3006654680
- 3005497913
- 8043933
- 3009381600
Source Documents#
Other 510(k) Records For Product Code OLO#
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|---|---|---|---|
| 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 |
| 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 |