SITTER 3.5mm Versatile System— 510(k) K240318
Substantially EquivalentBonebridge AG
FDA 510(k) clearance K240318 for SITTER 3.5mm Versatile System, Substantially Equivalent on 2024-08-23. Applicant: Bonebridge AG. Device class: 2.
Clearance details
- Applicant
- Bonebridge AG
- Product code
- Product 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
- Zug, CH
Recent devices under product code HRS
view allMore clearances from Bonebridge AG
view all- K261351 — SALGINA 2.5mm Distal Radius System
- K260228 — POYA 3.5mm Medial Proximal Tibia System
- K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
- K250933 — LORRAINE 2.5/3.5mm Distal Humerus System
- K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
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.