VOLT Proximal Humerus 3.5 Plating System— 510(k) K233994
Substantially EquivalentSynthes GmbH
FDA 510(k) clearance K233994 for VOLT Proximal Humerus 3.5 Plating System, Substantially Equivalent on 2024-07-26. Applicant: Synthes GmbH. Device class: 2.
Clearance details
- Applicant
- Synthes GmbH
- 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
- Zuchwil, CH
Recent devices under product code HRS
view allMore clearances from Synthes GmbH
view all- K254093 — DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System
- K260069 — DePuy Synthes VOLT Proximal Tibia 3.5 Plating System
- K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
- K243715 — Synthes Patient Specific Implants
- K241927 — Synthes Graphic Case & Tray 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.