Lima Intl. Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Lima Intl. Corp.” (first 1989, latest 1994), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 156 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 | 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Lima Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922613 | CL HIP STEM H/A COATED | MEH | 1994-04-05 | 672 |
| K910836 | LIMA COLLARED CL STEM | JDI | 1991-06-14 | 107 |
| K896851 | PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC | JDI | 1991-01-01 | 392 |
| K900051 | MOORE TYPE ENDO PROSTHESIS | KWY | 1990-10-03 | 273 |
| K902621 | SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT | JDI | 1990-09-11 | 89 |
| K896850 | LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE | LZO | 1990-06-05 | 182 |
| K900257 | MULLER TYPE ACETABULAR CUP | JDI | 1990-04-18 | 91 |
| K885146 | CL UNIVERSAL HIP DEVICE | KWI | 1989-04-24 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Lima Intl. Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lima Corporate S.P.A. (64 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lima Intl. Corp.?
FDA lists 8 510(k) clearances under the applicant name “Lima Intl. Corp.” (first 1989, latest 1994), across 5 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 Lima Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lima Intl. Corp. is 156 days.
Which FDA product codes appear under Lima Intl. Corp.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 4); KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer, 1); KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, 1).
Next steps
- See all 8 Lima Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Lima Intl. Corp.'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.