Custom Spine, Inc.: FDA clearances and approvals
Custom Spine, Inc. has 14 FDA 510(k) clearances (first 2005, latest 2015), across 7 product codes in 1 review panel. Median 510(k) review time: 91 days. openFDA lists 1 product recall by a recalling firm named Custom Spine, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 231 |
| 2013 | 1 | 430 |
| 2014 | 1 | 235 |
| 2015 | 1 | 261 |
| 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 | 5 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| 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 |
Review panels
- Orthopedic (14)
Most recent Custom Spine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143143 | PATHWAY ELIF | MAX | 2015-07-22 | 261 |
| K132596 | PROPOSED OPTIMUS | OVD | 2014-04-11 | 235 |
| K120597 | KOMPREDA | MRW | 2013-05-03 | 430 |
| K111726 | PATHWAY AVID | MAX | 2012-02-06 | 231 |
| K111774 | PATHWAY MODEL 07XXXX | MAX | 2011-07-20 | 27 |
| K111099 | ISSYS LP SPINAL FIXATION SYSTEM | NKB | 2011-05-05 | 15 |
| K101151 | REGENT ANTERIOR CERVICAL PLATE | KWQ | 2010-05-19 | 26 |
| K092904 | PATHWAY IVB/VBR | ODP | 2009-12-22 | 92 |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | KWQ | 2009-08-17 | 119 |
| K090566 | PATHWAY AVID | MAX | 2009-06-01 | 90 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-03-28.
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 Custom Spine, Inc. have?
Custom Spine, Inc. has 14 FDA 510(k) clearances (first 2005, latest 2015), across 7 product codes in 1 review panel.
How long does FDA take to clear Custom Spine, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Custom Spine, Inc.'s cleared 510(k)s is 91 days.
What devices does Custom Spine, Inc. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 5); KWP (Appliance, Fixation, Spinal Interlaminal, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Has Custom Spine, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Custom Spine, Inc; the most recent began 2013-03-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 14 Custom Spine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Custom 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.