LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
FDA 510(k) clearance K001238 · decided 2000-05-03
Clearance details
- K-number
- K001238
- Device name
- LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
- Applicant
- Walter Lorenz Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-18
- Decision date
- 2000-05-03
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization a recall (Z-0282-2009) | Biomet Microfixation, Inc. | 2008-11-04 |