LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
FDA 510(k) clearance K972322 · decided 1997-08-18
Clearance details
- K-number
- K972322
- Device name
- LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
- Applicant
- Walter Lorenz Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-20
- Decision date
- 1997-08-18
- Days to decision
- 59 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product U recall (Z-0629-2021) | Biomet, Inc. | 2020-12-17 |