Lanx, Inc.
Broomfield, CO, US
Lanx, Inc. appears in FDA device records in Broomfield, CO. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Lanx, Inc. between 2008 and 2013. The busiest year on record is 2011, with 8. The most recent is 2013, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 6 |
| 2010 | 5 |
| 2011 | 8 |
| 2012 | 4 |
| 2013 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131547 | LANX FUSION SYSTEM | OVD | Substantially Equivalent | |
| K131156 | LANX SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K123767 | LANX FUSION SYSTEM- SA | OVD | Substantially Equivalent | |
| K121316 | LANX SPINAL FIZATION SYSTEM | NKB | Substantially Equivalent | |
| K122145 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K121940 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K120399 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | NKB | Substantially Equivalent | |
| K112388 | LANX CERVICAL SA | OVE | Substantially Equivalent | |
| K103091 | LANX SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K103237 | LANX SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K103666 | LANX LATERAL | MAX | Substantially Equivalent | |
| K103660 | LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | ODP | Substantially Equivalent | |
| K102738 | LANX FUSION SYSTEM | OVD | Substantially Equivalent | |
| K103040 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | NKB | Substantially Equivalent | |
| K100888 | MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K101364 | LANX FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K100935 | LANX SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K100191 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | KWP | Substantially Equivalent | |
| K092765 | LANX ANTERIOR PLATING SYSTEM | KWQ | Substantially Equivalent | |
| K093285 | MODIFICATION TO LANX SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K092656 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K083815 | LANX FUSION SYSTEM | MAX | Substantially Equivalent | |
| K090316 | MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K083581 | LANX SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K090252 | MODIFICATION TO: LANX SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K082774 | LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K073144 | LANX INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
This record is listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0400-2014 | 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 consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae. | Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain