LANX FUSION SYSTEM- SA
FDA 510(k) clearance K123767 · decided 2013-03-18
Clearance details
- K-number
- K123767
- Device name
- LANX FUSION SYSTEM- SA
- Applicant
- Lanx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-07
- Decision date
- 2013-03-18
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Broomfield, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timb recall (Z-0982-2015) | Biomet Spine, LLC | 2015-01-15 |
| Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Ancho recall (Z-0983-2015) | Biomet Spine, LLC | 2015-01-15 |
| Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 8630 recall (Z-0978-2015) | Biomet Spine, LLC | 2015-01-14 |
| LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Shor recall (Z-0400-2014) | Lanx, Inc. | 2013-11-26 |