THE BIOPLATE SHUNT CONNECTOR— 510(k) K984583
Substantially EquivalentBiomedics
FDA 510(k) clearance K984583 for THE BIOPLATE SHUNT CONNECTOR, Substantially Equivalent on 1999-03-15. Applicant: Biomedics. Device class: 2.
Clearance details
- Applicant
- Biomedics
- Product code
- Code JXG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5550
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code JXG
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- K980983 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K972463 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K961976 — THE BIOPLATE FIXATION SYSTEM
- K953273 — BIOPLATE RIGID FIXATION BONE PLATING SYSTEM
Adverse events under product code JXG
product code JXG- Death
- 76
- Injury
- 5,632
- Malfunction
- 2,230
- Other
- 4
- Total
- 7,942
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.