Zsfab, Inc.: FDA clearances and approvals
Zsfab, Inc. has 7 FDA 510(k) clearances (first 2021, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 91 days. Since 2017 its median was 91 days, against 107 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 129 |
| 2022 | 1 | 109 |
| 2023 | 1 | 30 |
| 2024 | 1 | 58 |
| 2025 | 1 | 99 |
| 2026 | 2 | 78 |
Review time against the same product codes
Since 2017, Zsfab, Inc.'s cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Zsfab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261451 | ZSAlign Cervical Interbody System | OVE | 2026-07-31 | 91 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | ODP | 2026-04-24 | 65 |
| K252610 | ZSFab Lumbar Interbody System | MAX | 2025-11-25 | 99 |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | ODP | 2024-11-07 | 58 |
| K232150 | ZSFab Cervical Interbody System | ODP | 2023-08-18 | 30 |
| K221858 | ZSFab Lumbar Interbody System | MAX | 2022-10-14 | 109 |
| K202488 | ZSFab Cervical Interbody System | ODP | 2021-01-07 | 129 |
Recalls
openFDA lists no recalls under a recalling firm named Zsfab, Inc..
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 Zsfab, Inc. have?
Zsfab, Inc. has 7 FDA 510(k) clearances (first 2021, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear Zsfab, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Zsfab, Inc.'s cleared 510(k)s is 91 days. Since 2017: 91 days, versus 107 days for all cleared 510(k)s in the same product codes.
What devices does Zsfab, Inc. make?
Its most frequent FDA product codes are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 1).
Has Zsfab, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Zsfab, Inc. Related entities may recall under other names.
Next steps
- See all 7 Zsfab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ODP, Zsfab, Inc.'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.