Zavation Medical Products, LLC: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Zavation Medical Products, LLC” (first 2018, latest 2026), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 93 days. Since 2017 the median was 93 days, against 90 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 |
|---|---|---|
| 2018 | 7 | 96 |
| 2019 | 5 | 69 |
| 2020 | 4 | 120 |
| 2021 | 4 | 72 |
| 2022 | 4 | 110 |
| 2023 | 4 | 147 |
| 2024 | 1 | 162 |
| 2025 | 1 | 46 |
| 2026 | 1 | 226 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zavation Medical Products, LLC took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 9 | 9 |
| NKB | Thoracolumbosacral Pedicle Screw System | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 | 2 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (31)
Most recent Zavation Medical Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253943 | Tiger 2 System | NKB | 2026-07-24 | 226 |
| K243908 | Tiger 2 System | NKB | 2025-02-03 | 46 |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | MAX | 2024-04-10 | 162 |
| K231811 | Zavation Connector System | NKB | 2023-08-22 | 62 |
| K223808 | Zavation Navigation Instrument System | OLO | 2023-07-12 | 204 |
| K230731 | Zavation ALIF System | OVD | 2023-06-14 | 90 |
| K221726 | Uni-FuZe-C Bone Strip | MQV | 2023-01-18 | 218 |
| K222614 | Zavation Spinal System | NKB | 2022-12-05 | 97 |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | OVE | 2022-08-12 | 123 |
| K220581 | Zavation eZspand Interbody System | MAX | 2022-06-02 | 93 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zavation Medical Products, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zavation, LLC (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zavation Medical Products, LLC?
FDA lists 31 510(k) clearances under the applicant name “Zavation Medical Products, LLC” (first 2018, latest 2026), across 11 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 Zavation Medical Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zavation Medical Products, LLC is 93 days. Since 2017: 93 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zavation Medical Products, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 9); NKB (Thoracolumbosacral Pedicle Screw System, 7); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4).
Next steps
- See all 31 Zavation Medical Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Zavation Medical Products, LLC'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.