DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)— 510(k) K211051
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K211051 for DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System), Substantially Equivalent on 2021-06-02. 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.