Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinefrontier, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
250 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2020-06-19 | 224 | 0 |
| K172484 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2018-05-08 | 264 | 0 |
| K151198 | A-CIFT SoloFuse | Spinefrontier, Inc. | 2015-07-17 | 73 | 0 |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015-05-13 | 250 | 0 |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | Spinefrontier, Inc. | 2015-04-24 | 109 | 0 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 | 79 | 0 |
| K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Spinefrontier, Inc. | 2014-11-25 | 188 | 0 |
| K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY F | Spinefrontier, Inc. | 2014-10-20 | 87 | 0 |
| K141337 | ARENA-C | Spinefrontier, Inc. | 2014-09-08 | 110 | 0 |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2014-05-14 | 209 | 0 |
| K131880 | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION | Spinefrontier, Inc. | 2014-01-03 | 192 | 0 |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYST | Spinefrontier, Inc. | 2013-11-26 | 84 | 0 |
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2013-02-15 | 129 | 6 |
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM | Spinefrontier, Inc. | 2012-07-03 | 88 | 6 |
| K113518 | ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Spinefrontier, Inc. | 2012-02-16 | 79 | 0 |
| K111553 | SPINEFRONTIER LUMBAR IBF SYSTEM | Spinefrontier, Inc. | 2011-09-28 | 117 | 0 |
| K102020 | VEGA SPAN SPINOUS PROCESS PLATE SYSTEM | Spinefrontier, Inc. | 2010-09-01 | 44 | 0 |
| K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE | Spinefrontier, Inc. | 2010-06-30 | 289 | 6 |
| K093776 | INDUS ANTERIOR CERVICAL PLATE SYSTEM | Spinefrontier, Inc. | 2010-03-26 | 108 | 0 |
| K092420 | KRD1 PEDICLE SCREW SYSTEM | Spinefrontier, Inc. | 2009-11-19 | 105 | 2 |
| K091638 | DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 | Spinefrontier, Inc. | 2009-09-14 | 102 | 0 |
| K073232 | INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX | Spinefrontier, Inc. | 2008-02-20 | 97 | 0 |
| K071420 | CHAMELEON FIXATION SYSTEM | Spinefrontier, Inc. | 2008-01-16 | 239 | 1 |
| K072289 | SPINEFRONTIER DORADO VBR | Spinefrontier, Inc. | 2007-11-01 | 77 | 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