BIOPLATE RESORBABLE BONE SCREW— 510(k) K012908
Substantially EquivalentBioplate, Inc.
FDA 510(k) clearance K012908 for BIOPLATE RESORBABLE BONE SCREW, Substantially Equivalent on 2001-11-28. Applicant: Bioplate, Inc.. Device class: 2.
Clearance details
- Applicant
- Bioplate, Inc.
- Product code
- Code DZL
- Device class
- Class 2
- Regulation
- 21 CFR 872.4880
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code DZL
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 DZL
product code DZL- Injury
- 168
- Total
- 168
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.