Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Business Development, 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) |
|---|---|---|---|---|---|
| K072029 | PHENIX VERTEBRAL BODY REPLACEMENT | New Business Development, LLC | 2007-10-15 | 83 | 0 |
| K050377 | NBD HEAD SCREW | New Business Development, LLC | 2005-04-07 | 51 | 0 |
| K032196 | NBD DISPOSABLE RF CANNULAE | New Business Development, LLC | 2003-10-09 | 83 | 0 |
| K021788 | NBD CEMENT RESTRICTOR DEVICE | New Business Development, LLC | 2002-10-04 | 126 | 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