Atlas FDA

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

Syntec Scientific Corporation · Predicate Candidate Screening

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

330 daysmedian FDA review time
392 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K202790Syntec Orthodontic Mini Screw Extended SystemSyntec Scientific Corporation2021-09-173600
K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation2020-10-28290
K200933Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation2020-05-05280
K191617Syntec Tibial Nail SystemSyntec Scientific Corporation2019-09-03770
K181296Syntec Femoral Nail SystemSyntec Scientific Corporation2019-04-113300
K161327SYNTEC HUMERAL NAIL SYSTEMSyntec Scientific Corporation2017-06-083920

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