Levtech, Inc.: FDA clearances and approvals
Levtech, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1991), across 5 product codes in 3 review panels. Median 510(k) review time: 144 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 |
|---|---|---|---|
| HAX | Tong, Skull For Traction | 1 | 1 |
| HTD | Forceps | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
- Orthopedic (3)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent Levtech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910128 | LEVTECH TITANIUM BONE WIRE | JDQ | 1991-06-18 | 160 |
| K901144 | LEVTECH BONE SCREW | HWC | 1990-10-10 | 212 |
| K873693 | LEVTECH COMPOSITE TRACTION TONGS | HAX | 1988-02-05 | 144 |
| K874023 | LEVTECH CLAMP APPLIER | HTD | 1987-11-06 | 35 |
| K850039 | HALIFAX SPINAL CLAMP | KWP | 1985-05-29 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Levtech, 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 Levtech, Inc. have?
Levtech, Inc. has 5 FDA 510(k) clearances (first 1985, latest 1991), across 5 product codes in 3 review panels.
How long does FDA take to clear Levtech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Levtech, Inc.'s cleared 510(k)s is 144 days.
What devices does Levtech, Inc. make?
Its most frequent FDA product codes are HAX (Tong, Skull For Traction, 1); HTD (Forceps, 1); HWC (Screw, Fixation, Bone, 1).
Has Levtech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Levtech, Inc. Related entities may recall under other names.
Next steps
- See all 5 Levtech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAX, Levtech, 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.