Syntec-Taichung Non-Sterile Dhs/Dcs Plate System
FDA 510(k) K983873 · Syntec Scientific Corp.
510(k) numberK983873
Submission
- Device name
- Syntec-Taichung Non-Sterile Dhs/Dcs Plate System
- Applicant
- Syntec Scientific Corp.
Chang Hua, TW - Received
- November 2, 1998
- Decision date
- December 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K181296 | Syntec Femoral Nail SystemHSB · Traditional | 04/11/2019SE |
| K161327 | Syntec Humeral Nail SystemHSB · Traditional | 06/08/2017SE |
| K111189 | Syntec Dental ImplantDZE · Traditional | 12/20/2012SE |
| K101971 | Syntec Os Spinal Fixation SystemNKB · Traditional | 03/25/2011SE |
| K092889 | Syntec Osteo-Plate and Screw FixationHRS · Traditional | 06/25/2010SE |
| K090476 | Syntec Orthodontic Mini ScrewOAT · Traditional | 06/18/2009SE |
Questions and answers
When was Syntec-Taichung Non-Sterile Dhs/Dcs Plate System cleared by the FDA?
Syntec-Taichung Non-Sterile Dhs/Dcs Plate System (K983873) received a 510(k) decision of Substantially Equivalent on December 30, 1998, 58 days after the submission was received.
What is the product code of K983873?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.