Amendia, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Amendia, Inc.” (first 2009, latest 2016), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 154 |
| 2015 | 4 | 116 |
| 2016 | 7 | 177 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MRW | System, Facet Screw Spinal Device | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (16)
Most recent Amendia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160924 | Amendia Interbody Fusion Devices | MAX | 2016-11-08 | 218 |
| K161842 | Overwatch Spine System | NKB | 2016-10-13 | 100 |
| K152920 | Savannah-T® Pedicle Screw System | NKB | 2016-07-08 | 280 |
| K153152 | Syzygy Stabilization System | NKB | 2016-04-27 | 177 |
| K160291 | Optimus ALIF System | OVD | 2016-02-18 | 15 |
| K152972 | Amendia Stand-Alone Cervical System | OVE | 2016-01-14 | 98 |
| K151310 | Amendia Interbody Fusion Devices | MAX | 2016-01-06 | 233 |
| K152460 | Rectangular Corpectomy Cage | MQP | 2015-12-22 | 116 |
| K152455 | Amendia Cervical Plate System | KWQ | 2015-10-15 | 48 |
| K151322 | Amendia Interbody Fusion Devices | MAX | 2015-09-10 | 115 |
6 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2017-07-07.
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 Amendia, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Amendia, Inc.” (first 2009, latest 2016), across 8 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 Amendia, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amendia, Inc. is 116 days.
Which FDA product codes appear under Amendia, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); NKB (Thoracolumbosacral Pedicle Screw System, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 16 Amendia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Amendia, Inc.'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.