Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgical Implant Generation Network (Sign) — 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) |
|---|---|---|---|---|---|
| K083582 | SIGN HIP CONSTRUCT (SHC), MODEL: 701 | Surgical Implant Generation Network (Sign) | 2009-08-26 | 265 | 0 |
| K043200 | SIGN FIN NAIL | Surgical Implant Generation Network (Sign) | 2005-02-03 | 77 | 0 |
| K022632 | SIGN IM NAIL | Surgical Implant Generation Network (Sign) | 2002-09-23 | 47 | 0 |
| K013132 | SIGN IM NAIL | Surgical Implant Generation Network (Sign) | 2001-12-20 | 92 | 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