Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sulzer Spine-Tech — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

64 daysmedian FDA review time
90 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022374CADENCE SPINAL FIXATION SYSTEMSulzer Spine-Tech2002-09-24641
K020344RPX TITANIUM CEMNT RESTRICTORSulzer Spine-Tech2002-05-02900
K020196MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEMSulzer Spine-Tech2002-02-15240
K012173DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEMSulzer Spine-Tech2001-09-28780
K012305MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEMSulzer Spine-Tech2001-08-22300
K993067SILHOUETTE SPINAL FIXATION SYSTEMSulzer Spine-Tech1999-11-16640
K992276MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEMSulzer Spine-Tech1999-10-01860

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