Genesys Spine Sacroiliac Joint Fusion System with Navigation— 510(k) K233595

Clearance details

Applicant

Genesys Spine

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2023-11-08

Decision date

2024-03-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

• K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
• K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K252322 — SIros-X System2025-10-22
• K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System2025-02-07
• K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System2023-12-13
• K220096 — Genesys Spine 3DP Lumbar Interbody System2022-03-09
• K191489 — Genesys Spine 3DP Cervical Interbody System2020-01-08

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →