Suzhou Endophix Co., Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Megaloop Button System510(k)May 3, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 3, 2024
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor510(k)Nov 2, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 2, 2023
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)510(k)Jun 7, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 7, 2023
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath510(k)May 23, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 23, 2023