Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Endius, Inc. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
144 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080258 | MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER TH | Endius, Inc. | 2008-03-10 | 39 | 0 |
| K073510 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | Endius, Inc. | 2008-02-11 | 60 | 0 |
| K073267 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION | Endius, Inc. | 2008-01-30 | 71 | 0 |
| K072840 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Endius, Inc. | 2007-12-07 | 64 | 0 |
| K070282 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION | Endius, Inc. | 2007-09-06 | 220 | 0 |
| K070367 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Endius, Inc. | 2007-04-12 | 63 | 0 |
| K061345 | MODIFICATION TO ENDIUS ATAVI SYSTEM | Endius, Inc. | 2006-06-06 | 22 | 1 |
| K060990 | ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM | Endius, Inc. | 2006-04-26 | 16 | 0 |
| K060683 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION | Endius, Inc. | 2006-04-18 | 34 | 0 |
| K053267 | ENDIUS ATAVI SYSTEM | Endius, Inc. | 2006-01-13 | 51 | 1 |
| K041808 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM | Endius, Inc. | 2004-10-01 | 87 | 1 |
| K022199 | ENDIUS ATAVI SYSTEM | Endius, Inc. | 2002-10-02 | 89 | 0 |
| K022578 | ENDIUS FLEXTIP BLADE | Endius, Inc. | 2002-08-23 | 18 | 0 |
| K021881 | ENDIUS TITLE SPINAL FIXATION SYSTEM | Endius, Inc. | 2002-07-29 | 52 | 0 |
| K021748 | ENDIUS ATAVI SYSTEM | Endius, Inc. | 2002-06-26 | 29 | 0 |
| K014090 | ENDIUS SPINAL FIXATION SYSTEM | Endius, Inc. | 2002-03-11 | 90 | 0 |
| K014107 | ENDIUS CERVICAL PLATE SYSTEM | Endius, Inc. | 2002-02-13 | 62 | 0 |
| K013403 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-11-14 | 30 | 0 |
| K012488 | MODIFICATION TO:ENDIUS BIPOLAR SHEATH | Endius, Inc. | 2001-08-30 | 27 | 0 |
| K011830 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-07-23 | 41 | 0 |
| K010903 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-06-06 | 72 | 0 |
| K010922 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-06-06 | 71 | 0 |
| K003897 | ENDIUS BIPOLAR SHEATH | Endius, Inc. | 2001-03-22 | 94 | 0 |
| K010535 | TRIFIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2001-03-19 | 24 | 0 |
| K002437 | ENDIUS ENDOSCOPIC ACCESS SYSTEM | Endius, Inc. | 2000-10-02 | 54 | 0 |
| K001627 | TRIFIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2000-06-03 | 8 | 0 |
| K000766 | TRI-FIX SPINAL FIXATION SYSTEM | Endius, Inc. | 2000-06-01 | 84 | 0 |
| K994425 | MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM | Endius, Inc. | 2000-02-16 | 48 | 0 |
| K992535 | ENDIUS SUCTION/IRRIGATION INSTRUMENT | Endius, Inc. | 1999-09-01 | 34 | 0 |
| K991794 | ENDOSCOPIC SPINAL ACCESS SYSTEM | Endius, Inc. | 1999-08-13 | 79 | 0 |
| K983144 | FLEXPOSURE RETRACTOR | Endius, Inc. | 1999-02-24 | 169 | 0 |
| K982819 | ENDIUS SPINE ENDOSCOPE | Endius, Inc. | 1999-01-27 | 169 | 0 |
| K972450 | FLEXTIP GRASPER | Endius, Inc. | 1997-11-21 | 144 | 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