Enztec Limited

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0612-2020Class IIREF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only withAugust 16, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K232014CONDUIT™ ATP InsertersSeptember 1, 2023
K230876RI.KNEE Adjustable Tibia Cut GuideJune 27, 2023
K223671CONDUIT LLIF Straight InsertersJanuary 5, 2023
K220449DePuy CONDUIT LLIF SQUID InserterJune 28, 2022
K212823DePuy CONDUIT LLIF Angled InsertersNovember 1, 2021