Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JDN · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
150 daysmedian FDA review time
313 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954856 | CANNULATED FEMORAL NAIL | Synthes (Usa) | 1996-03-08 | 137 | 0 |
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Stuart | 1990-06-21 | 176 | 0 |
| K894184 | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | Biedermann Motech GmbH | 1990-04-25 | 313 | 0 |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Roseburg SA | 1987-12-07 | 150 | 0 |
| K873977 | NEW C-D SYSTEM FOR SPINAL SURGERY | Sofamor Co. | 1987-12-07 | 69 | 0 |
| K760649 | TOTAL SPINAL CORRECTION | Depuy, Inc. | 1976-10-05 | 20 | 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