MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY— 510(k) K023665
Substantially EquivalentBioplate, Inc.
FDA 510(k) clearance K023665 for MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, Substantially Equivalent on 2002-11-22. Applicant: Bioplate, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioplate, Inc.
- Product code
- Code JEY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Los Angeles, CA, US
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More clearances from Bioplate, Inc.
view all- K082757 — MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
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- K070901 — MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K062819 — BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K051845 — THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
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.