CarboClear® Cervical Navigated Instruments— 510(k) K263154
Substantially EquivalentCarboFix Orhtopedics , Ltd.
FDA 510(k) clearance K263154 for CarboClear® Cervical Navigated Instruments, Substantially Equivalent on 2026-10-09. Applicant: CarboFix Orhtopedics , Ltd.. Device class: 2.
Summary
CarboClear Cervical Navigated Instruments are filed under OLO, orthopedic stereotaxic instruments. The name points to navigated instruments for cervical use; the record doesn't list which navigation systems they work with.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), and the decision was Substantially Equivalent. The record lists Neurology as the classification panel.
CarboFix filed from Herzeliya, Israel. Review took 30 days (September 9 to October 9, 2026).
Clearance details
- Applicant
- CarboFix Orhtopedics , Ltd.
- 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
- Special
- Location
- Herzeliya, IL
Recent devices under product code OLO
view all- 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
- K261024 — TMINI Miniature Robotic System
Adverse 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.