X-Spine Systems, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “X-Spine Systems, Inc.” (first 2004, latest 2018), across 14 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. Since 2017 the median was 112 days, against 89 days for all cleared 510(k)s in the same product codes. 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 | 160 |
| 2013 | 6 | 112 |
| 2014 | 2 | 144 |
| 2015 | 2 | 79 |
| 2016 | 4 | 68 |
| 2017 | 5 | 112 |
| 2018 | 2 | 102 |
| 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 X-Spine Systems, Inc. took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 | 7 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 | 3 |
| MRW | System, Facet Screw Spinal Device | 2 | 2 |
| OUR | Sacroiliac Joint Fixation | 2 | 2 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
Plus 4 more product codes.
Review panels
- Orthopedic (35)
Most recent X-Spine Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173832 | InTice-C Porous Ti Cervical Interbody System | ODP | 2018-05-17 | 150 |
| K180153 | X-spine Cortical Bone Screw System | NKB | 2018-03-15 | 55 |
| K170119 | Calix Lumbar Spinal Implant System | MAX | 2017-09-29 | 259 |
| K171567 | IRIX-A Lumbar Integrated Fusion System | OVD | 2017-08-28 | 90 |
| K171075 | Calix-C Cervical Interbody Spacer | ODP | 2017-08-01 | 112 |
| K170224 | Spider Cervical Plating System | KWQ | 2017-07-06 | 162 |
| K170530 | Butrex Lumbar Buttress Plating System | KWQ | 2017-03-22 | 28 |
| K160959 | Xsert Lumbar Expandable Interbody System | MAX | 2016-11-17 | 226 |
| K162944 | Irix-C Cervical Integrated Fusion System | OVE | 2016-11-07 | 17 |
| K160428 | Certex Spinal Fixation System | NKG | 2016-05-05 | 79 |
25 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2016-05-17.
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:
- X-Spine Systems, Inc. (34)
- X-Spine Systems (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under X-Spine Systems, Inc.?
FDA lists 35 510(k) clearances under 2 spellings of the applicant name “X-Spine Systems, Inc.” (first 2004, latest 2018), across 14 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 X-Spine Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name X-Spine Systems, Inc. is 103 days. Since 2017: 112 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under X-Spine Systems, Inc.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 7); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); KWP (Appliance, Fixation, Spinal Interlaminal, 3).
Next steps
- See all 35 X-Spine Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, X-Spine Systems, 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.