Landos, Inc.: FDA clearances and approvals
Landos, Inc. has 15 FDA 510(k) clearances (first 1994, latest 1997), across 6 product codes in 1 review panel. Median 510(k) review time: 233 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 6 | 6 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| LZN | Cement Obturator | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Landos, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964226 | MEMORY STAPLE (20 SIZES AVAILABLE) | JDR | 1997-08-05 | 286 |
| K971070 | SCARF THREAD-HEAD (TM) HEAD SCREW | HWC | 1997-07-09 | 107 |
| K971069 | TWIST-OFF (TM) SCREW | HWC | 1997-07-09 | 107 |
| K971068 | 34MM SCARF THREAD-HEAD(TM) SCREW | HWC | 1997-07-09 | 107 |
| K961732 | KAR | MEH | 1997-07-08 | 431 |
| K970846 | 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD | LZO | 1997-06-05 | 90 |
| K953111 | CORAIL | LZO | 1996-12-27 | 543 |
| K962233 | TWIST-OFF SCREW | HWC | 1996-10-03 | 114 |
| K962236 | SCARF THREAD-HEAD SCREW | HWC | 1996-09-20 | 101 |
| K960642 | NANCY NAIL | HTY | 1996-05-17 | 93 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Landos, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Landos, Inc. have?
Landos, Inc. has 15 FDA 510(k) clearances (first 1994, latest 1997), across 6 product codes in 1 review panel.
How long does FDA take to clear Landos, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Landos, Inc.'s cleared 510(k)s is 233 days.
What devices does Landos, Inc. make?
Its most frequent FDA product codes are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 6); HWC (Screw, Fixation, Bone, 5); HTY (Pin, Fixation, Smooth, 1).
Has Landos, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Landos, Inc. Related entities may recall under other names.
Next steps
- See all 15 Landos, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZO, Landos, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.