THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM— 510(k) K013050
Substantially EquivalentBioplate, Inc.
FDA 510(k) clearance K013050 for THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM, Substantially Equivalent on 2001-12-10. Applicant: Bioplate, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioplate, Inc.
- 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
- Los Angeles, CA, US
Recent devices under product code GXN
view allMore clearances from Bioplate, Inc.
view all- K082757 — MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
- K082175 — MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
- 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 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.