510(k) K123767 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
LANX FUSION SYSTEM- SA
| Applicant | Lanx, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Mar 18, 2013 |
| Received | Dec 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123767
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2015 | Biomet Spine, LLC Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.
Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into Terminated |
OVD | None listed |
| Jan 15, 2015 | Biomet Spine, LLC Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into t Terminated |
OVD | None listed |
| Jan 14, 2015 | Biomet Spine, LLC Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204
Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF Terminated |
OVD | None listed |
| Nov 26, 2013 | Lanx, Inc. LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107.
The Timberline MPF device is an intervertebral body fusion device consi Terminated |
OVD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.