Atlas FDA

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

Sofamor Co. — Predicate Candidate Screening

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

214 daysmedian FDA review time
712 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940744SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATIONSofamor Co.1996-01-307120
K945022APOFIX CERVICAL SPINE FIXATIONSofamor Co.1995-05-152140
K934007SOFAMOR ORFIL SPINE FIXATION SYSTEMSofamor Co.1994-06-022880
K873977NEW C-D SYSTEM FOR SPINAL SURGERYSofamor Co.1987-12-07690
K843687ROD FOR RACHIS SURGERYSofamor Co.1985-01-101140

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