Enztec Limited: FDA clearances and approvals
Enztec Limited has 5 FDA 510(k) clearances (first 2021, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time: 59 days. Since 2017 its median was 59 days, against 99 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Enztec Limited.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 59 |
| 2022 | 1 | 132 |
| 2023 | 3 | 57 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Enztec Limited's cleared 510(k)s took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Enztec Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232014 | CONDUIT ATP Inserters | MAX | 2023-09-01 | 57 |
| K230876 | RI.KNEE Adjustable Tibia Cut Guide | OLO | 2023-06-27 | 89 |
| K223671 | CONDUIT LLIF Straight Inserters | MAX | 2023-01-05 | 29 |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | MAX | 2022-06-28 | 132 |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | MAX | 2021-11-01 | 59 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-08-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Enztec Limited have?
Enztec Limited has 5 FDA 510(k) clearances (first 2021, latest 2023), across 2 product codes in 1 review panel.
How long does FDA take to clear Enztec Limited's 510(k)s?
The median time from FDA receipt to decision across Enztec Limited's cleared 510(k)s is 59 days. Since 2017: 59 days, versus 99 days for all cleared 510(k)s in the same product codes.
What devices does Enztec Limited make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); OLO (Orthopedic Stereotaxic Instrument, 1).
Has Enztec Limited had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Enztec Limited; the most recent began 2019-08-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Enztec Limited clearances with predicates and recalls
- Run predicate analysis for product code MAX, Enztec Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.