Amedica Corp.: FDA clearances and approvals
Amedica Corp. has 17 FDA 510(k) clearances (first 2002, latest 2018), across 7 product codes in 1 review panel. Median 510(k) review time: 91 days. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 56 |
| 2013 | 0 | — |
| 2014 | 2 | 102 |
| 2015 | 1 | 294 |
| 2016 | 2 | 100 |
| 2017 | 0 | — |
| 2018 | 1 | 119 |
| 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, Amedica Corp.'s cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 | 1 |
Review panels
- Orthopedic (17)
Most recent Amedica Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173453 | Valeo® C+CSC with Lumen Interbody Fusion Device | ODP | 2018-03-05 | 119 |
| K162160 | Preference Elite Pedicle Screw System | NKB | 2016-11-18 | 108 |
| K161405 | Valeo II Interbody Fusion Device System | MAX | 2016-08-19 | 91 |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System | MAX | 2015-10-02 | 294 |
| K142264 | Valeo C Spacer System, Valeo II C IBF Device | ODP | 2014-12-08 | 115 |
| K142347 | Amedica Valeo II Interbody Fusion Device | MAX | 2014-11-18 | 88 |
| K121892 | PHANTOM PLUS CERAMIC CAGE SYSTEM | MAX | 2012-08-24 | 56 |
| K091278 | VALEO SPACER SYSTEM | MAX | 2010-01-28 | 272 |
| K082037 | SEEPLATE CERVICAL PLATE SYSTEM | KWQ | 2008-09-26 | 71 |
| K073430 | VALEO PEDICLE SCREW SPINAL SYSTEM | NKB | 2008-01-29 | 54 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amedica Corp..
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.
Device clinical trials
Amedica Corp. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01557829: Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial (Completed, started 2012-02)
- NCT01511445: Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome (Completed, started 2011-12)
Frequently asked questions
How many FDA 510(k) clearances does Amedica Corp. have?
Amedica Corp. has 17 FDA 510(k) clearances (first 2002, latest 2018), across 7 product codes in 1 review panel.
How long does FDA take to clear Amedica Corp.'s 510(k)s?
The median time from FDA receipt to decision across Amedica Corp.'s cleared 510(k)s is 91 days.
What devices does Amedica Corp. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); MQP (Spinal Vertebral Body Replacement Device, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Has Amedica Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Amedica Corp. Related entities may recall under other names.
Next steps
- See all 17 Amedica Corp. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Amedica Corp.'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.