Zavation, LLC: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Zavation, LLC” (first 2011, latest 2017), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 169 days, against 95 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 |
|---|---|---|
| 2012 | 1 | 30 |
| 2013 | 1 | 111 |
| 2014 | 3 | 111 |
| 2015 | 1 | 245 |
| 2016 | 3 | 149 |
| 2017 | 3 | 169 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zavation, LLC took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 95 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| NDN | Cement, Bone, Vertebroplasty | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
| PEK | Spinous Process Plate | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Zavation, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162206 | Zavation IBF | MAX | 2017-04-04 | 242 |
| K162575 | Z-LINKPC System | NKG | 2017-03-03 | 169 |
| K162824 | Z-Span Plate System | KWQ | 2017-02-17 | 133 |
| K161016 | Z-Clamp ISP System | PEK | 2016-10-19 | 191 |
| K153404 | Zavation Spinal System | MNH | 2016-04-21 | 149 |
| K160362 | Z-Span Plate System | KWQ | 2016-03-22 | 42 |
| K142392 | Zavation Posterior LEIF | MAX | 2015-04-29 | 245 |
| K142271 | Zavation Z-Link Lumbar | OVD | 2014-12-19 | 126 |
| K141419 | ZVPLASTY | NDN | 2014-09-12 | 106 |
| K141005 | Z-LINK CERVICAL | OVE | 2014-08-07 | 111 |
5 earlier clearances. See the full list in Caduvo.
Recalls
71 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-03-25.
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 Medical Products, LLC (31 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zavation, LLC?
FDA lists 15 510(k) clearances under the applicant name “Zavation, LLC” (first 2011, latest 2017), across 10 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, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zavation, LLC is 111 days. Since 2017: 169 days, versus 95 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zavation, LLC?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 15 Zavation, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Zavation, 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.