Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gold Standard Orthopaedics, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123487 | GSO GS1 CANNULATED SCREW SYSTEM | Gold Standard Orthopaedics, LLC | 2013-03-11 | 118 | 0 |
| K091359 | GSO PCT SPINAL SYSTEM | Gold Standard Orthopaedics, LLC | 2009-09-02 | 117 | 0 |
| K070966 | GSO GS1 SPINAL SYSTEM | Gold Standard Orthopaedics, LLC | 2007-07-20 | 106 | 0 |
| K063589 | GSO BONE FIXATION FASTENERS | Gold Standard Orthopaedics, LLC | 2007-01-31 | 61 | 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