Enztec Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Enztec Limited” (first 2021, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 59 days. Since 2017 the median was 59 days, against 99 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Enztec Limited 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Enztec Limited?
FDA lists 5 510(k) clearances under the applicant name “Enztec Limited” (first 2021, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Enztec Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Enztec Limited is 59 days. Since 2017: 59 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Enztec Limited?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); OLO (Orthopedic Stereotaxic Instrument, 1).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.