DePuy Synthes Variable Angle Locking Patella Plating System— 510(k) K201578
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K201578 for DePuy Synthes Variable Angle Locking Patella Plating System, Substantially Equivalent on 2020-09-09. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- 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 Synthes (USA) Products, LLC
view all- K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- K212943 — SyntheCel Dura Repair
- K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
- K210408 — DePuy Synthes Variable Angle Locking Patella Plating System
- K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur 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.