LORENZ RESORBABLE DISTRACTOR SYSTEM
FDA 510(k) clearance K002083 · decided 2001-02-12
Clearance details
- K-number
- K002083
- Device name
- LORENZ RESORBABLE DISTRACTOR SYSTEM
- Applicant
- Walter Lorenz Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-10
- Decision date
- 2001-02-12
- Days to decision
- 217 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 |
|---|---|---|
| Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THI recall (Z-0383-2012) | Walter Lorenz Surgical, Inc. | 2012-01-11 |
| Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS recall (Z-0384-2012) | Walter Lorenz Surgical, Inc. | 2012-01-11 |
| Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVI recall (Z-0385-2012) | Walter Lorenz Surgical, Inc. | 2012-01-11 |