Synthes Patient Specific Implants— 510(k) K243715
Substantially EquivalentSynthes GmbH
FDA 510(k) clearance K243715 for Synthes Patient Specific Implants, Substantially Equivalent on 2025-11-12. Applicant: Synthes GmbH. Device class: 2.
Clearance details
- Applicant
- Synthes GmbH
- Product code
- Code GXN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zuchwil, CH
Recent devices under product code GXN
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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
- K241927 — Synthes Graphic Case & Tray System
- K233994 — VOLT Proximal Humerus 3.5 Plating System
Adverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
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.