Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spine Smith Partners L.P. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
99 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122630 | IN:C2 SPINAL FIXATION SYSTEM | Spine Smith Partners L.P. | 2012-12-05 | 99 | 0 |
| K122168 | VISUALIF CHALLENGING ACCESS PLATE | Spine Smith Partners L.P. | 2012-10-11 | 80 | 0 |
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION I | Spine Smith Partners L.P. | 2010-09-30 | 66 | 1 |
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM | Spine Smith Partners L.P. | 2010-07-01 | 73 | 1 |
| K090376 | SPINESMITH CYNCH SPINAL SYSTEM | Spine Smith Partners L.P. | 2009-04-01 | 43 | 0 |
| K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYS | Spine Smith Partners L.P. | 2008-10-31 | 36 | 0 |
| K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYS | Spine Smith Partners L.P. | 2008-07-14 | 84 | 0 |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | 2008-07-02 | 89 | 0 |
| K073320 | CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | 2008-02-07 | 73 | 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