Poly-Medics,Inc.: FDA clearances and approvals
Poly-Medics,Inc. has 5 FDA 510(k) clearances (first 1994, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time: 106 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 2 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
Review panels
Most recent Poly-Medics,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960988 | LACTOSORB TRAUMA PLATING SYSTEM | HRS | 1996-04-10 | 34 |
| K955729 | LACTOSORB TRAUMA PLATING SYSTEM | HRS | 1996-02-14 | 58 |
| K954443 | LACTOSORB SUTURE ANCHOR | JDR | 1996-01-31 | 128 |
| K951658 | LACTOSORB POP RIVET | JDR | 1995-07-25 | 106 |
| K934861 | HARD TISSUE REPLACEMENT (HTR) GRANULAR | KKY | 1994-11-04 | 388 |
Recalls
openFDA lists no recalls under a recalling firm named Poly-Medics,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 Poly-Medics,Inc. have?
Poly-Medics,Inc. has 5 FDA 510(k) clearances (first 1994, latest 1996), across 3 product codes in 2 review panels.
How long does FDA take to clear Poly-Medics,Inc.'s 510(k)s?
The median time from FDA receipt to decision across Poly-Medics,Inc.'s cleared 510(k)s is 106 days.
What devices does Poly-Medics,Inc. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 2); JDR (Staple, Fixation, Bone, 2); KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, 1).
Has Poly-Medics,Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Poly-Medics,Inc. Related entities may recall under other names.
Next steps
- See all 5 Poly-Medics,Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Poly-Medics,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.