Apollo Spine, Inc.: FDA clearances and approvals
Apollo Spine, Inc. has 7 FDA 510(k) clearances (first 2009, latest 2012), across 6 product codes in 1 review panel. Median 510(k) review time: 171 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 144 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 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 |
Review panels
- Orthopedic (7)
Most recent Apollo Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120340 | VENUS FACET SCREW SYSTEM | MRW | 2012-10-19 | 259 |
| K120143 | ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL | ODP | 2012-02-16 | 29 |
| K102636 | ZENITH PEDICLE SYSTEM | MNH | 2011-03-03 | 171 |
| K102121 | ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR | OVD | 2011-01-12 | 167 |
| K101588 | ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL | OVE | 2011-01-07 | 214 |
| K090751 | COMET ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2009-10-23 | 217 |
| K082504 | APOLLO ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2009-01-27 | 151 |
Recalls
openFDA lists no recalls under a recalling firm named Apollo Spine, 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 Apollo Spine, Inc. have?
Apollo Spine, Inc. has 7 FDA 510(k) clearances (first 2009, latest 2012), across 6 product codes in 1 review panel.
How long does FDA take to clear Apollo Spine, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Apollo Spine, Inc.'s cleared 510(k)s is 171 days.
What devices does Apollo Spine, Inc. make?
Its most frequent FDA product codes are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1); MRW (System, Facet Screw Spinal Device, 1).
Has Apollo Spine, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Apollo Spine, Inc. Related entities may recall under other names.
Next steps
- See all 7 Apollo Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Apollo Spine, 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.