Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinal Concepts, Inc. — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
165 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE | Spinal Concepts, Inc. | 2005-05-19 | 29 | 0 |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | Spinal Concepts, Inc. | 2005-04-15 | 28 | 1 |
| K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM | Spinal Concepts, Inc. | 2004-07-01 | 163 | 0 |
| K033663 | SPINAL CONCEPTS INC. CODA | Spinal Concepts, Inc. | 2004-05-27 | 188 | 0 |
| K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS | Spinal Concepts, Inc. | 2004-02-18 | 103 | 1 |
| K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM | Spinal Concepts, Inc. | 2003-09-17 | 93 | 1 |
| K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2003-09-11 | 76 | 4 |
| K031318 | TRAXIS CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2003-08-22 | 119 | 0 |
| K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM | Spinal Concepts, Inc. | 2003-08-07 | 69 | 0 |
| K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2003-07-24 | 38 | 0 |
| K030087 | SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM | Spinal Concepts, Inc. | 2003-07-17 | 189 | 0 |
| K031914 | SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE | Spinal Concepts, Inc. | 2003-07-12 | 22 | 0 |
| K030625 | SPINAL CONCEPTS INC. PATHFINDER | Spinal Concepts, Inc. | 2003-03-28 | 29 | 6 |
| K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLAT | Spinal Concepts, Inc. | 2003-01-23 | 28 | 4 |
| K023647 | CADENCE PEEK CEMEENT RESTRICTOR | Spinal Concepts, Inc. | 2002-11-27 | 28 | 0 |
| K023644 | MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2002-11-25 | 26 | 1 |
| K021564 | INCOMPASS SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2002-10-25 | 165 | 1 |
| K021719 | FORTITUDE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2002-08-15 | 84 | 0 |
| K022218 | CADENCE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2002-08-12 | 34 | 0 |
| K021009 | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM | Spinal Concepts, Inc. | 2002-06-18 | 82 | 0 |
| K020611 | UNIVERSAL BONE PLATE III SYSTEM (UBP III) | Spinal Concepts, Inc. | 2002-03-27 | 30 | 0 |
| K013979 | SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM | Spinal Concepts, Inc. | 2002-02-13 | 72 | 2 |
| K013887 | BACFIX SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 2002-02-12 | 81 | 0 |
| K010563 | END-TO-END AND SIDE-BY-SIDE CONNECTORS | Spinal Concepts, Inc. | 2001-05-25 | 88 | 0 |
| K003351 | PARSFIX CABLE-SCREW SYSTEM | Spinal Concepts, Inc. | 2001-01-24 | 90 | 0 |
| K002082 | SPEEDLINK TRANSVERSE CONNECTOR | Spinal Concepts, Inc. | 2000-10-06 | 88 | 8 |
| K990005 | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM | Spinal Concepts, Inc. | 1999-02-12 | 39 | 1 |
| K983260 | MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SY | Spinal Concepts, Inc. | 1998-10-21 | 35 | 1 |
| K983258 | MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTE | Spinal Concepts, Inc. | 1998-10-21 | 35 | 1 |
| K973687 | SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 1998-03-18 | 173 | 0 |
| K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM | Spinal Concepts, Inc. | 1997-12-19 | 58 | 0 |
| K973586 | SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II | Spinal Concepts, Inc. | 1997-11-07 | 46 | 0 |
| K964404 | BACFIX SPINAL FIXATION SYSTEM | Spinal Concepts, Inc. | 1997-03-26 | 142 | 1 |
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