Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Bioretec with 9 510(k) clearances. The most recent is a 510(k) clearance dated Sep 4, 2026: ActivaScrew™ Cannulated COM.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 4, 2026 | ActivaScrew™ Cannulated COMK261057 · HWC | 510(k) clearances |
| Mar 29, 2023 | RemeOs™ Screw LAG SolidDEN220030 · QJD | 510(k) clearances |
| Jan 22, 2014 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)K133950 · HTY | 510(k) clearances |
| Aug 28, 2013 | BIORETEC ACTIVASCREW INTERFERENCEK130716 · MAI | 510(k) clearances |
| Jun 24, 2008 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMK080879 · HTY | 510(k) clearances |
| Jun 18, 2008 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPINK081392 · HWC | 510(k) clearances |
| Nov 2, 2007 | ACTIVASCREWK072848 · HWC | 510(k) clearances |
| Aug 31, 2007 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)K071863 · HTY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
