Surgtech Inc

FDA Filings

This page includes the latest FDA filings for Surgtech Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Surgtech Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• WUHAN YIJIABAO BIOLOGICAL MATERIALS CO.,LTD.

FDA Registration(s)

• Registration Number: 3011170410
• FEI Number: 3011170410
• Name: SURGTECH, INC.
• Owner & Operator: SurgTech, Inc.
• Contact Address: 24600 Center Ridge Road, Suite 195 ; Westlake OH 44145 US
• Official Correspondent:
  • Cheng Bao
  • 1-440-8992922-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 24600 Center Ridge Road, Suite 195 ; Westlake, OH 44145 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K191192 SurgTech, Inc.	SurgTech GENOLL Total Knee System	2019-08-01
PMN K173455 SurgTech, Inc.,	SurgTech Bipolar Head System	2018-06-14
PMN K163363 | NKB SURGTECH, INC.	SurgTech Posterior Fixation Screw System	2017-08-22
PMN K163363 | KWP SURGTECH, INC.	SurgTech Posterior Fixation Screw System	2017-08-22
PMN K162125 | LZO SURGTECH, INC.	SurgTech Total Hip	2017-08-22
PMN K162125 | LPH SURGTECH, INC.	SurgTech Total Hip	2017-08-22
PMN K162125 | JDI SURGTECH, INC.	SurgTech Total Hip	2017-08-22
PMN K161894 | HWC SURGTECH, INC.	SurgTech Trauma System	2017-08-22
PMN K161894 | HRS SURGTECH, INC.	SurgTech Trauma System	2017-08-22
PMN K162125 SurgTech, Inc.,	MALUC™ Total Hip Arthroplasty System	2017-05-10
PMN K163363 SurgTech Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
PMN K161894 SURGTECH INC	SurgTech Trauma System	2017-02-21
PMN K152200 | MAX SURGTECH, INC.	SurgTech Interbody System	2016-06-01
PMN K152200 SURGTECH INC	SurgTech Interbody System	2016-03-25