MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
FDA 510(k) clearance K082757 · decided 2008-10-01
Clearance details
- K-number
- K082757
- Device name
- MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
- Applicant
- Bioplate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-19
- Decision date
- 2008-10-01
- Days to decision
- 12 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 Titanium Fixation System, Sterile Kit. The sterile plate and screw kit configurat recall (Z-0143-2012) | Bioplate Inc | 2011-11-01 |