Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Spine, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
109 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K090060 | NEXLINK OCT SYSTEM, MODEL 7000 SERIES | Abbott Spine, Inc. | 2009-06-02 | 144 | 0 |
| K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CON | Abbott Spine, Inc. | 2008-10-06 | 81 | 1 |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Abbott Spine, Inc. | 2008-08-29 | 80 | 0 |
| K073202 | ARDIS SPACER | Abbott Spine, Inc. | 2008-01-30 | 78 | 1 |
| K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES | Abbott Spine, Inc. | 2007-11-28 | 68 | 2 |
| K071174 | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS | Abbott Spine, Inc. | 2007-07-25 | 89 | 4 |
| K062505 | NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX S | Abbott Spine, Inc. | 2006-09-26 | 29 | 0 |
| K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODEL | Abbott Spine, Inc. | 2006-03-31 | 22 | 4 |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | Abbott Spine, Inc. | 2006-03-06 | 62 | 0 |
| K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODEL | Abbott Spine, Inc. | 2006-01-06 | 109 | 4 |
| K052638 | ABBOTT SPINE, INC. SPINNAKER SYSTEM | Abbott Spine, Inc. | 2005-11-07 | 42 | 0 |
| K052247 | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 72 | Abbott Spine, Inc. | 2005-09-14 | 27 | 4 |
| K052072 | THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE L | Abbott Spine, Inc. | 2005-08-29 | 28 | 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