Navigated LLIF Impactable Tracker— 510(k) K261060
Substantially EquivalentTyber Medical, LLC
FDA 510(k) clearance K261060 for Navigated LLIF Impactable Tracker, Substantially Equivalent on 2026-05-29. Applicant: Tyber Medical, LLC. Device class: 2.
Summary
Tyber Medical's Navigated LLIF Impactable Tracker is filed under OLO, orthopedic stereotaxic instruments.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Tyber filed from Bethlehem, Pennsylvania. Review took 59 calendar days (March 31 to May 29, 2026).
Clearance details
- Applicant
- Tyber Medical, LLC
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code OLO
view all- K263154 — CarboClear® Cervical Navigated Instruments
- K262257 — Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
- K262506 — Remex Spine Surgery Navigation - Universal Instruments
- K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
- K261205 — SPINEART Navigation Instrument System
More clearances from Tyber Medical, LLC
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.