510(k) K213708
- Device
- ROSA® Knee System
- Applicant
- Orthosoft, Inc (d/b/a Zimmer CAS)
- 510(k) number
- K213708
- Product code
- OLO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-22
- Date received
- 2021-11-24
- 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
- Paul Hardy
- Address
- 75 Queen St. Suite 3300 Montreal CA H3C 2N6 H3C 2N6
FDA Registration Numbers#
- 2249615
- 3003678543
- 3009380063
- 3007922509
- 9617544
- 3006654680
- 2133786
- 3010057495
- 3012447612
- 2648623
- 3025343017
- 3004635447
- 3004638600
- 3015536273
- 3010141593
- 3003387384
- 3040335671
- 1424434
- 3005819474
- 9611827
- 3006493760
- 3043543260
- 3014479313
- 3011656326
- 3015542154
- 3009417901
- 2027487
- 3015179588
- 1056553
- 3011795235
- 3003955307
- 3001284227
- 3027305794
- 1833824
- 3005216725
- 2133641
- 3025110439
- 3014782362
- 3010120339
- 3019807891
- 3010041430
- 3021948057
- 3009394448
- 3005874553
- 3013404959
- 2531477
- 3011187779
- 9611579
- 2530808
- 1423662
- 3003541440
- 3010370554
- 1018470
- 3004976965
- 2134947
- 3009973505
- 3015399803
- 3027153110
- 3010531060
- 2953359
- 3010123206
- 3010120135
- 3025603301
- 1064858
- 3000719653
- 2031917
- 3012131184
- 3013194153
- 3021902355
- 3009337690
- 1835251
- 3017410889
- 3021632375
- 1314417
- 3039520898
- 1834331
- 3009185973
- 1225492
- 9680515
- 3005751028
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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases