# Syntec Scientific Corp.

- Location (FDA's records): Chang Hua, TW
- FDA decisions: 19 (1998–2021): 19 510(k) clearances
- Names in FDA's records: Syntec Scientific Corp. (13); Syntec Scientific Corporation (6)
- Product codes: HSB (6), HRS (3), OAT (2), KTT (2), JDW (2), HWC (1), DZE (1), NKB (1), HTY (1)
- 510(k) review time since 2016: median 330 days, against 132 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 17 (10 its own); citations of its devices by later devices: 39 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentium Co., Ltd.: 2 (https://510kreport.com/company/dentium)
- Leone S.P.A.: 1 (https://510kreport.com/company/leone)
- I.T.S. GmbH: 1 (https://510kreport.com/company/its)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)

## Firms that cite its devices most
- New Deal, S.A.: 3 (https://510kreport.com/company/new-deal)
- Microware Precision Co., Ltd.: 3 (https://510kreport.com/company/microware-precision)
- In2bones USA, LLC: 2 (https://510kreport.com/company/in2bones-usa)
- Intai Technology Corporation: 2 (https://510kreport.com/company/intai-technology)
- Intelligent Orthopaedics, Ltd.: 1 (https://510kreport.com/company/intelligent-orthopaedics)
- In2bones Sas: 1 (https://510kreport.com/company/in2bones)
- Sonoma Orthopedics Products, Inc.: 1 (https://510kreport.com/company/sonoma-orthopedics-products)
- Syntec Scientific Corporation - Taipei Office: 1 (https://510kreport.com/company/syntec-scientific-taipei-office)

## Its most-cited devices
- K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420 (1998), cited by 11
- K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 (1998), cited by 7
- K090476: Syntec Orthodontic Mini Screw (2009), cited by 6
- K092889: Syntec Osteo-Plate and Screw Fixation (2010), cited by 3
- K983988: Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate (1999), cited by 3
- K984543: Syntec-Taichung Non-Sterile Interlocking Nail System, Model:Humerus:256-000/280, Femur:274-000/870, Tibia:249-300/420 25 (1999), cited by 3

## Recent decisions
- K202790: Syntec Orthodontic Mini Screw Extended System (Sep 17, 2021)
- K202935: Syntec Femoral Nail Extended System (Oct 28, 2020)
- K200933: Syntec Non-Sterile Steinmann Pins System (May 5, 2020)
- K191617: Syntec Tibial Nail System (Sep 3, 2019)
- K181296: Syntec Femoral Nail System (Apr 11, 2019)
- K161327: Syntec Humeral Nail System (Jun 8, 2017)
- K111189: Syntec Dental Implant (Dec 20, 2012)
- K101971: Syntec OS Spinal Fixation System (Mar 25, 2011)

Source page: https://510kreport.com/company/syntec-scientific