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

Sintea Biotech, Inc. — Predicate Candidate Screening

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

74 daysmedian FDA review time
334 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XSintea Biotech, Inc.2009-04-072040
K081631SINTEA BIOTECH PLS MULTI-AXIAL SCREWSSintea Biotech, Inc.2008-07-18370
K072198X-VOID, SPIDERSintea Biotech, Inc.2008-06-063040
K070181SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.TSintea Biotech, Inc.2007-04-18890
K060513SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.XSintea Biotech, Inc.2006-03-10110
K043355SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RESintea Biotech, Inc.2004-12-17110
K041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.XSintea Biotech, Inc.2004-09-16550
K031154SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.XSintea Biotech, Inc.2003-06-24740
K020085SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.XSintea Biotech, Inc.2002-12-103340
K022065SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.XSintea Biotech, Inc.2002-08-06420

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