Atlas FDA

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

Syntec Scientific Corp. — Predicate Candidate Screening

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

72 daysmedian FDA review time
277 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K111189SYNTEC DENTAL IMPLANTSyntec Scientific Corp.2012-12-206020
K101971SYNTEC OS SPINAL FIXATION SYSTEMSyntec Scientific Corp.2011-03-252550
K092889SYNTEC OSTEO-PLATE AND SCREW FIXATIONSyntec Scientific Corp.2010-06-252770
K090476SYNTEC ORTHODONTIC MINI SCREWSyntec Scientific Corp.2009-06-181140
K090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCSyntec Scientific Corp.2009-04-24280
K984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTESyntec Scientific Corp.1999-03-05670
K984364SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEMSyntec Scientific Corp.1999-03-02850
K984543SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:Syntec Scientific Corp.1999-03-01700
K983988SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATESyntec Scientific Corp.1999-01-27790
K983873SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEMSyntec Scientific Corp.1998-12-30580
K983495SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MSyntec Scientific Corp.1998-12-16720
K983757SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONSyntec Scientific Corp.1998-12-04420
K983121NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 2Syntec Scientific Corp.1998-10-05270

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