Company · FI
Bioretec, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2026 | K261057 | ActivaScrew Cannulated COM Bioretec, Ltd., FI | HWC |
| Mar 29, 2023 | DEN220030 | RemeOs Screw LAG Solid Bioretec, Ltd., FI | QJD |
| Jan 22, 2014 | K133950 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) Bioretec, Ltd., FI | HTY |
| Aug 28, 2013 | K130716 | BIORETEC ACTIVASCREW INTERFERENCE Bioretec, Ltd., FI | MAI |
| Jun 24, 2008 | K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM Bioretec, Ltd., FI | HTY |
| Jun 18, 2008 | K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN Bioretec, Ltd., FI | HWC |
| Nov 2, 2007 | K072848 | ACTIVASCREW Bioretec, Ltd., FI | HWC |
| Aug 31, 2007 | K071863 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) Bioretec, Ltd., FI | HTY |
| Nov 22, 2006 | K062980 | ACTIVASCREW Bioretec, Ltd., FI | HWC |
| Jul 6, 2006 | K061164 | ACTIVAPIN Bioretec, Ltd., FI | HTY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||