Lanx, Inc.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Lanx, Inc.” (first 2004, latest 2013), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 30 |
| 2013 | 3 | 44 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 9 | 9 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (36)
Most recent Lanx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131547 | LANX FUSION SYSTEM | OVD | 2013-07-12 | 44 |
| K131156 | LANX SPINAL FIXATION SYSTEM | KWP | 2013-05-24 | 30 |
| K123767 | LANX FUSION SYSTEM- SA | OVD | 2013-03-18 | 101 |
| K121316 | LANX SPINAL FIZATION SYSTEM | NKB | 2012-09-10 | 131 |
| K122145 | LANX SPINAL FIXATION SYSTEM | NKB | 2012-08-17 | 29 |
| K121940 | LANX SPINAL FIXATION SYSTEM | NKB | 2012-08-02 | 31 |
| K120399 | LANX SPINAL FIXATION SYSTEM | NKB | 2012-03-09 | 30 |
| K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | NKB | 2011-12-19 | 28 |
| K112388 | LANX CERVICAL SA | OVE | 2011-12-16 | 120 |
| K103091 | LANX SPINAL FIXATION SYSTEM | KWP | 2011-04-15 | 178 |
26 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-11-04.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lanx, Inc.?
FDA lists 36 510(k) clearances under the applicant name “Lanx, Inc.” (first 2004, latest 2013), across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lanx, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lanx, Inc. is 80 days.
Which FDA product codes appear under Lanx, Inc.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 9); KWP (Appliance, Fixation, Spinal Interlaminal, 7); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 5).
Next steps
- See all 36 Lanx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Lanx, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.