Interventional Spine, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Interventional Spine, Inc.” (first 2008, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 | 51 |
| 2013 | 1 | 42 |
| 2014 | 2 | 164 |
| 2015 | 1 | 77 |
| 2016 | 1 | 45 |
| 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 | 6 | 6 |
| MRW | System, Facet Screw Spinal Device | 2 | 2 |
Review panels
- Orthopedic (8)
Most recent Interventional Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160464 | Opticage(R) Expandable Interbody Fusion Device | MAX | 2016-04-04 | 45 |
| K152156 | Opticage Expandable Interbody Fusion Device | MAX | 2015-10-19 | 77 |
| K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE | MAX | 2014-11-24 | 248 |
| K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 | MAX | 2014-02-10 | 81 |
| K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 | MAX | 2013-09-19 | 42 |
| K113527 | OPTICAGE INTERBODY FUSION DEVICE | MAX | 2012-01-20 | 51 |
| K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER | MRW | 2009-06-11 | 80 |
| K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT | MRW | 2008-12-12 | 80 |
Recalls
10 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2016-11-22.
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.
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.
- Interventional Therapeutics Corp. (28 510(k)s)
- Interventional Medical, Inc. (4 510(k)s)
- Interventional Innovations Corp. (2 510(k)s)
- Interventional Concepts, Inc. (1 510(k)s)
- Interventional Research Technologies (1 510(k)s)
- Interventional Thermodynamics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Interventional Spine, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Interventional Spine, Inc.” (first 2008, latest 2016), across 2 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 Interventional Spine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interventional Spine, Inc. is 78 days.
Which FDA product codes appear under Interventional Spine, Inc.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 6); MRW (System, Facet Screw Spinal Device, 2).
Next steps
- See all 8 Interventional Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Interventional 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, 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.