CROSSNAV Navigation Enabled Instruments— 510(k) K233255
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K233255 for CROSSNAV Navigation Enabled Instruments, Substantially Equivalent on 2024-06-17. Applicant: DePuy Synthes. Device class: 2.
Clearance details
- Applicant
- DePuy Synthes
- Product code
- 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
- Oberdor, CH
Recent devices under product code OLO
view allMore clearances from DePuy Synthes
view all- K233696 — DePuy Synthes Retrograde Femoral Nail Advanced System
- K233256 — Robotic Integration Instruments
- K233254 — TELIGEN System Navigation Ready Instruments
- K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
- K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT 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.