MatrixRIB Fixation System— 510(k) K190409
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K190409 for MatrixRIB Fixation System, Substantially Equivalent on 2019-05-03. Applicant: DePuy Synthes. Device class: 2.
Clearance details
- Applicant
- DePuy Synthes
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code HRS
view allMore clearances from DePuy Synthes
view all- K233696 — DePuy Synthes Retrograde Femoral Nail Advanced System
- K233255 — CROSSNAV Navigation Enabled Instruments
- 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
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.