# Enztec Limited

- Location (FDA's records): Middleton, NZ
- FDA decisions: 5 (2021–2023): 5 510(k) clearances
- Product codes: MAX (4), OLO (1)
- 510(k) review time since 2016: median 59 days, against 90 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medos International SARL: 2 (https://510kreport.com/company/medos-international)
- Eit Emerging Implant Technologies GmbH: 2 (https://510kreport.com/company/eit-emerging-implant-technologies)
- Blue Belt Technologies, Inc.: 1 (https://510kreport.com/company/blue-belt-technologies)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)

## Its most-cited devices
- K212823: DePuy CONDUIT LLIF Angled Inserters (2021), cited by 2
- K223671: CONDUIT LLIF Straight Inserters (2023), cited by 1

## Recent decisions
- K232014: CONDUIT™ ATP Inserters (Sep 1, 2023)
- K230876: RI.KNEE Adjustable Tibia Cut Guide (Jun 27, 2023)
- K223671: CONDUIT LLIF Straight Inserters (Jan 5, 2023)
- K220449: DePuy CONDUIT LLIF SQUID Inserter (Jun 28, 2022)
- K212823: DePuy CONDUIT LLIF Angled Inserters (Nov 1, 2021)

Source page: https://510kreport.com/company/enztec