SYNTHES CERVICAL VERTABRAE PLATES— 510(k) K792352
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K792352 for SYNTHES CERVICAL VERTABRAE PLATES, Substantially Equivalent on 1979-12-06. Applicant: DePuy Synthes. Device class: 2.
Clearance details
- Applicant
- DePuy Synthes
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
Recent devices under product code KWQ
view allMore clearances from DePuy Synthes
view all- K233696 — DePuy Synthes Retrograde Femoral Nail Advanced System
- K233255 — CROSSNAV Navigation Enabled Instruments
- K233256 — Robotic Integration Instruments
- K233254 — TELIGEN System Navigation Ready Instruments
- K233665 — DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.