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

Scien'Tx USA, Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time
203 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020245MODIFICATION TO ISOBAR SPINAL SYSTEMScien'Tx USA, Inc.2002-02-0180
K013447ISOBAR SPINAL SYSTEMScien'Tx USA, Inc.2002-01-15900
K013439ANTERIOR CERVICAL PLATE SYSTEMScien'Tx USA, Inc.2002-01-14890
K013440ISOBAR SPINAL SYSTEMScien'Tx USA, Inc.2001-11-16300
K013444ISOBAR SPINAL SYSTEMScien'Tx USA, Inc.2001-11-16300
K991326ISOBAR SEMI-RIGID SPINAL SYSTEMScien'Tx USA, Inc.1999-11-082030
K990721ISOLOCK SPINAL SYSTEMScien'Tx USA, Inc.1999-05-27830
K990118ISOBAR SPINAL SYSTEMScien'Tx USA, Inc.1999-03-22680

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