Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arcan Orthopaedic Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
899 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971457 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED | Arcan Orthopaedic Corp. | 1997-07-16 | 110 | 0 |
| K955927 | BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) | Arcan Orthopaedic Corp. | 1996-03-13 | 82 | 0 |
| K953416 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | Arcan Orthopaedic Corp. | 1995-10-03 | 85 | 0 |
| K945435 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | Arcan Orthopaedic Corp. | 1995-05-31 | 236 | 0 |
| K914548 | BRYAN SPINAL FIXATER (BSF) | Arcan Orthopaedic Corp. | 1994-03-28 | 899 | 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