Apollo Spine, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Apollo Spine, Inc.” (first 2009, latest 2012), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 171 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 | 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 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Apollo Spine, Inc. (6)
- Apollo Spine (1)
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.
- Apollo Endosurgery, Inc. (13 510(k)s)
- Apollo Enterprise, Ltd. Co. (3 510(k)s)
- Apollo Dental Products, Inc. (2 510(k)s)
- Apollo Medical Imaging Technology Pty. , Ltd. (2 510(k)s)
- Apollo Corp. (1 510(k)s)
- Apollo Fluid Dynamics (1 510(k)s)
- Apollo Medical Optics, Ltd. (1 510(k)s)
- Apollo Physical Therapy Products International (1 510(k)s)
- Apollo Products, Inc. (1 510(k)s)
- Apollo'S Suntanning Supplies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apollo Spine, Inc.?
FDA lists 7 510(k) clearances under 2 spellings of the applicant name “Apollo Spine, Inc.” (first 2009, latest 2012), across 6 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 Apollo Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apollo Spine, Inc. is 171 days.
Which FDA product codes appear under Apollo Spine, Inc.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1); MRW (System, Facet Screw Spinal Device, 1).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.