Navigated LLIF Impactable Tracker— 510(k) K261060

Clearance details

Applicant

Tyber Medical, LLC

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2026-03-31

Decision date

2026-05-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bethlehem, PA, 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

• K261207 — Exalta Proximal Tibia Plating System2026-06-12
• K260810 — Anteralign LS coverplate2026-06-10
• K253042 — Tyber Medical Trauma Screw2026-04-03
• K252901 — Tyber Medical Trauma Screw2025-12-31
• K252742 — Navigated Instruments2025-10-28

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 →