Artimplant AB: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Artimplant AB” (first 2003, latest 2007), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 125 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 2 | 2 |
Review panels
Most recent Artimplant AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071887 | SPORTMESH OR ARTELON TISSUE REINFORCEMENT | FTL | 2007-09-18 | 71 |
| K061956 | ARTELON STT SPACER | KYI | 2007-06-07 | 331 |
| K061954 | ARTELON CMC SPACER ARTHRO | KYI | 2007-06-01 | 325 |
| K052830 | SPORTMESH | FTL | 2006-01-19 | 106 |
| K052482 | ARTELON SURGICAL SUTURE | GAR | 2005-10-17 | 38 |
| K040070 | ARTELON SPACER CMC-1 | KYI | 2004-09-21 | 251 |
| K032160 | ARTELON SURGICAL SUTURE | GAR | 2003-11-17 | 125 |
Recalls
openFDA lists no recalls under a recalling firm named Artimplant AB.
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 Artimplant AB?
FDA lists 7 510(k) clearances under the applicant name “Artimplant AB” (first 2003, latest 2007), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Artimplant AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Artimplant AB is 125 days.
Which FDA product codes appear under Artimplant AB?
The most frequent FDA product codes under this applicant name are KYI (Prosthesis, Wrist, Carpal Trapezium, 3); FTL (Mesh, Surgical, Polymeric, 2); GAR (Suture, Nonabsorbable, Synthetic, Polyamide, 2).
Next steps
- See all 7 Artimplant AB clearances with predicates and recalls
- Run predicate analysis for product code KYI, Artimplant AB'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.