DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile— 510(k) K192327
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K192327 for DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile, Substantially Equivalent on 2019-11-07. 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
- Special
- 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.