THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM
FDA 510(k) clearance K051845 · decided 2005-07-27
Clearance details
- K-number
- K051845
- Device name
- THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM
- Applicant
- Bioplate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-07
- Decision date
- 2005-07-27
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 recall (Z-0043-2007) | Bioplate Inc | 2006-10-19 |