Company · NZ
Enztec Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2023. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2023 | K232014 | CONDUIT™ ATP Inserters Enztec Limited, NZ | MAX |
| Jun 27, 2023 | K230876 | RI.KNEE Adjustable Tibia Cut Guide Enztec Limited, NZ | OLO |
| Jan 5, 2023 | K223671 | CONDUIT LLIF Straight Inserters Enztec Limited, NZ | MAX |
| Jun 28, 2022 | K220449 | DePuy CONDUIT LLIF SQUID Inserter Enztec Limited, NZ | MAX |
| Nov 1, 2021 | K212823 | DePuy CONDUIT LLIF Angled Inserters Enztec Limited, NZ | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2020 | Enztec Limited REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE Terminated |
HWA | None listed |