The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Interlocking Nail System, Model:humerus:256-000/280, Femur:274-000/870, Tibia:249-300/420 25.
Device ID | K984543 |
510k Number | K984543 |
Device Name: | SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
Contact | Ted Y Shi |
Correspondent | Ted Y Shi SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-21 |
Decision Date | 1999-03-01 |
Summary: | summary |