MATRIXRIB FIXATION SYSTEM— 510(k) K133616
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K133616 for MATRIXRIB FIXATION SYSTEM, Substantially Equivalent on 2014-05-02. 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.