Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuvasive, Inc. — Predicate Candidate Screening
91 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
197 days90th percentile
91clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240507 | NuVasive AttraX Scaffold | Nuvasive, Inc. | 2024-03-20 | 28 | 0 |
| K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023-01-12 | 30 | 0 |
| K211757 | Simplify Disc | Nuvasive, Inc. | 2021-08-20 | 74 | 0 |
| K173117 | NuVasive® VersaTie™ System | Nuvasive, Inc. | 2017-12-07 | 69 | 0 |
| K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015-03-13 | 263 | 0 |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | Nuvasive, Inc. | 2015-02-20 | 193 | 0 |
| K141968 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2014-11-14 | 116 | 0 |
| K140319 | COROENT TI-C SYSTEM | Nuvasive, Inc. | 2014-10-09 | 241 | 0 |
| K140162 | AP EXPANDABLE XLIF SYSTEM | Nuvasive, Inc. | 2014-07-02 | 161 | 0 |
| K140003 | COROENT SMALL INTERBODY SYSTEM | Nuvasive, Inc. | 2014-04-03 | 91 | 0 |
| K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2013-12-20 | 84 | 0 |
| K131025 | ARCHON ANTERIOR CERVICAL PLATE SYSTEM | Nuvasive, Inc. | 2013-11-27 | 229 | 0 |
| K132014 | GSB GLOBAL SPINAL BALANCE SYSTEM | Nuvasive, Inc. | 2013-10-31 | 122 | 0 |
| K131723 | COROENT SINGLE TAB SYSTEM | Nuvasive, Inc. | 2013-09-20 | 100 | 0 |
| K130868 | NUVASIVE DECADE LATERAL PLATE SYSTEM | Nuvasive, Inc. | 2013-08-29 | 153 | 0 |
| K131238 | AFFIX SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2013-07-02 | 62 | 0 |
| K123307 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2013-04-23 | 181 | 0 |
| K123045 | BRIGADE STANDALONE SYSTEM | Nuvasive, Inc. | 2013-04-16 | 197 | 0 |
| K122081 | NUVASIVE LONG LATERAL SPINAL SYSTEM | Nuvasive, Inc. | 2013-02-01 | 200 | 0 |
| K122742 | NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM | Nuvasive, Inc. | 2012-12-07 | 91 | 0 |
| K121815 | NUVASIVE SAGE LATERAL PLATE SYSTEM | Nuvasive, Inc. | 2012-10-23 | 125 | 0 |
| K122352 | NUVASIVE PRECEPT SPINAL SYSTEM | Nuvasive, Inc. | 2012-09-11 | 39 | 0 |
| K121619 | NUVASIVE POLYAXIAL SPINAL SCREWS | Nuvasive, Inc. | 2012-08-24 | 84 | 0 |
| K121837 | NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM | Nuvasive, Inc. | 2012-07-16 | 24 | 0 |
| K120918 | NUVASIVE COROENT TITANIUM SYSTEM | Nuvasive, Inc. | 2012-06-28 | 93 | 0 |
| K112717 | NUVASIVE NVJJB SYSTEM | Nuvasive, Inc. | 2012-04-13 | 207 | 0 |
| K112718 | NUVASIVE NVM5 SYSTEM | Nuvasive, Inc. | 2012-03-16 | 179 | 0 |
| K112561 | NUVASIVE COROENT NO-PROFILE SYSTEM | Nuvasive, Inc. | 2012-03-13 | 193 | 0 |
| K111811 | BENDINI(TM) SPINAL ROD BENDING SYSTEM | Nuvasive, Inc. | 2011-12-05 | 161 | 0 |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | Nuvasive, Inc. | 2011-10-13 | 127 | 0 |
| K111866 | NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM | Nuvasive, Inc. | 2011-07-22 | 22 | 0 |
| K111410 | NUVASIVE LONG LATERAL SPINAL SYSTEM | Nuvasive, Inc. | 2011-06-20 | 32 | 0 |
| K103750 | NUVASIVE TRAVERSE PLATE SYSTEM | Nuvasive, Inc. | 2011-03-03 | 70 | 0 |
| K102547 | COROENT INTERLOCK SYSTEM | Nuvasive, Inc. | 2011-02-07 | 157 | 0 |
| K102514 | NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM | Nuvasive, Inc. | 2010-12-01 | 91 | 0 |
| K101284 | FACET SCREW SYSTEM | Nuvasive, Inc. | 2010-07-15 | 69 | 0 |
| K093319 | NUVASIVE VUEPOINT OCT SYSTEM | Nuvasive, Inc. | 2010-06-23 | 243 | 0 |
| K100043 | COROENT XLR STANDALONE SYSTEM | Nuvasive, Inc. | 2010-06-16 | 159 | 0 |
| K094054 | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE | Nuvasive, Inc. | 2010-05-14 | 134 | 0 |
| K093804 | NUVASIVE HELIX REVOLUTION ACP SYSTEM | Nuvasive, Inc. | 2010-02-19 | 70 | 0 |
| K091623 | LAMINOPLASTY FIXATION SYSTEM | Nuvasive, Inc. | 2009-10-09 | 128 | 0 |
| K092287 | NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM | Nuvasive, Inc. | 2009-10-06 | 69 | 0 |
| K091502 | NUVASIVE SPHERX II SYSTEM | Nuvasive, Inc. | 2009-07-22 | 62 | 0 |
| K090981 | MODIFICATION TO: NUVASIVE SPHERX SYSTEM | Nuvasive, Inc. | 2009-07-02 | 86 | 0 |
| K090298 | NUVASIVE NEURO VISION SYSTEM | Nuvasive, Inc. | 2009-06-08 | 122 | 0 |
| K091071 | NUVASIVE LATERAL PLATE SYSTEM | Nuvasive, Inc. | 2009-05-08 | 24 | 0 |
| K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM | Nuvasive, Inc. | 2009-04-27 | 94 | 1 |
| K083341 | NUVASIVE HELIX-T ACP SYSTEM | Nuvasive, Inc. | 2009-03-20 | 128 | 0 |
| K081377 | NUVASIVE SURGICAL MESH SYSTEM | Nuvasive, Inc. | 2009-01-15 | 244 | 0 |
| K083028 | MODIFICATION TO: NUVASIVE SPHERX II SYSTEM | Nuvasive, Inc. | 2008-11-13 | 34 | 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