Centinel Spine, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Centinel Spine, Inc.” (first 2010, latest 2018), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 137 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 | 1 | 165 |
| 2013 | 1 | 187 |
| 2014 | 4 | 99 |
| 2015 | 3 | 116 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 195 |
| 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 Centinel Spine, Inc. took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Centinel Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | MAX | 2018-05-08 | 195 |
| K152211 | PCT System | NKG | 2015-12-01 | 116 |
| K150053 | STALIF C; STALIF C-Ti | OVE | 2015-06-24 | 163 |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | OVD | 2015-06-08 | 88 |
| K141942 | MIDLINE II TI | OVD | 2014-11-07 | 113 |
| K142079 | STALIF CTI, STALIF C | OVE | 2014-10-24 | 85 |
| K133200 | STALIF C(R) | OVE | 2014-05-08 | 203 |
| K133286 | MIDLINE (TM) | OVD | 2014-01-09 | 76 |
| K130461 | STALIF X | OVD | 2013-08-28 | 187 |
| K120819 | STALIF C | OVE | 2012-08-31 | 165 |
1 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 4 recall events; 5 initiated in the last five years. Most recent: 2026-03-20.
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.
Device clinical trials
An industry sponsor named Centinel Spine, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT07370493: Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices (Enrolling by invitation, started 2025-11-01)
- NCT04012996: 2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C (Active not recruiting, started 2019-08-05)
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:
- Centinel Spine, Inc. (10)
- Centinel 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.
- Centinel Spine, LLC (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Centinel Spine, Inc.?
FDA lists 11 510(k) clearances under 2 spellings of the applicant name “Centinel Spine, Inc.” (first 2010, latest 2018), across 4 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 Centinel Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Centinel Spine, Inc. is 137 days.
Which FDA product codes appear under Centinel Spine, Inc.?
The most frequent FDA product codes under this applicant name are OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 11 Centinel Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OVD, Centinel 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.