Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinecraft, LLC — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
210 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Na | Spinecraft, LLC | 2023-07-20 | 266 | 0 |
| K223273 | ASTRA Spine System | Spinecraft, LLC | 2022-12-22 | 59 | 0 |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | 2021-09-30 | 100 | 0 |
| K211323 | ASTRA Spine System | Spinecraft, LLC | 2021-06-03 | 34 | 0 |
| K181350 | ASTRA-OCT Spine System | Spinecraft, LLC | 2018-07-06 | 45 | 0 |
| K143683 | APEX-DL Spine System | Spinecraft, LLC | 2015-05-22 | 149 | 0 |
| K150417 | ASTRA SPINE SYSTEM | Spinecraft, LLC | 2015-05-19 | 90 | 0 |
| K131521 | VELOX ANTERIOR CERVICAL PLATE SYSTEM | Spinecraft, LLC | 2013-12-24 | 210 | 0 |
| K132603 | APEX SPINE SYSTEM | Spinecraft, LLC | 2013-11-20 | 92 | 0 |
| K110906 | APEX SPINE SYSTEM | Spinecraft, LLC | 2011-07-26 | 117 | 0 |
| K103505 | ALTUM ANTERIOR CERVICAL PLATE | Spinecraft, LLC | 2011-03-15 | 106 | 1 |
| K102488 | APEX SPINE SYSTEM W/ COCR RODS | Spinecraft, LLC | 2010-12-10 | 101 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda