SpineCraft: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “SpineCraft” (first 2006, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 151 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 | 0 | — |
| 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 | 2 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name SpineCraft took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent SpineCraft 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253260 | ORIO-3D Cage System | ODP | 2026-04-16 | 199 |
| K260015 | ANTERIS Thoracolumbar Plate System | KWQ | 2026-03-04 | 58 |
| K092825 | APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER | KWP | 2010-03-16 | 186 |
| K090887 | ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES | ODP | 2009-10-30 | 213 |
| K062513 | APEX SPINE SYSTEM | KWP | 2006-12-22 | 116 |
| K062496 | OSTEOPORE TCP | MQV | 2006-10-19 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named SpineCraft.
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:
- SpineCraft (3)
- Spinecraft, Inc. (3)
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.
- Spinecraft, LLC (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under SpineCraft?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “SpineCraft” (first 2006, latest 2026), 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 SpineCraft?
The median time from FDA receipt to decision across 510(k)s cleared under the name SpineCraft is 151 days.
Which FDA product codes appear under SpineCraft?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 6 SpineCraft clearances with predicates and recalls
- Run predicate analysis for product code KWP, SpineCraft'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.