Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vertebron, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
104 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081567 | VERTEBRON SSP CERVICAL PLATING SYSTEM | Vertebron, Inc. | 2008-07-03 | 29 | 0 |
| K081597 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2008-07-02 | 26 | 0 |
| K073502 | VERTEBRON VBR SYSTEM | Vertebron, Inc. | 2008-03-24 | 102 | 0 |
| K071376 | MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2007-06-13 | 27 | 0 |
| K062110 | VERTEBRON SCP CERVICAL PLATE SYSTEM | Vertebron, Inc. | 2006-08-16 | 23 | 0 |
| K051815 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | Vertebron, Inc. | 2005-10-17 | 104 | 0 |
| K051716 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2005-09-07 | 72 | 0 |
| K043152 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2005-02-01 | 78 | 0 |
| K043181 | MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM | Vertebron, Inc. | 2004-12-17 | 30 | 0 |
| K040003 | VERTEBRON SCP CERVICAL PLATE SYSTEM | Vertebron, Inc. | 2004-03-26 | 84 | 0 |
| K033352 | VERTEBRON PSS PEDICLE SCREW SYSTEM | Vertebron, Inc. | 2004-02-25 | 128 | 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