Theken Companies L L C

FDA Filings

This page includes the latest FDA filings for Theken Companies L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Theken Companies L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.

FDA Registration(s)

• Registration Number: 3002498892
• FEI Number: 3002498892
• Name: THEKEN COMPANIES, LLC
• Owner & Operator: Theken Companies, LLC
• Contact Address: 1800 Triplett Blvd ; Akron OH 44306 US
• Official Correspondent:
  • Garrett Spurgeon
  • 1-330-7337600-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1800 Triplett Blvd ; Akron, OH 44306 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K192071 | OQI THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K192071 | OQG THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K192071 | LZO THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K192071 | LPH THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K191936 | OQI THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K191936 | OQG THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K191936 | LZO THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K191936 | LPH THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K191297 | KWY THEKEN COMPANIES, LLC	iNSitu Bipolar Hip System	2019-12-19
PMN K172501 | OQI THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K172501 | OQG THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K172501 | LZO THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K172501 | LPH THEKEN COMPANIES, LLC	iNSitu Total Hip System	2019-12-19
PMN K191297 Theken Companies, LLC	INSitu Bipolar Hip System	2019-09-17
PMN K192071 Theken Companies, LLC	INSitu Total Hip System	2019-08-30
LXH THEKEN COMPANIES, LLC	INSERTER\ADAPTER	2018-02-12
KIK THEKEN COMPANIES, LLC	BONE HOOK	2018-02-12
HXX THEKEN COMPANIES, LLC	SCREWDRIVER	2018-02-12
HWT THEKEN COMPANIES, LLC	TEMPLATE\TRIAL	2018-02-12
HWE THEKEN COMPANIES, LLC	QUICK CONNECT/ DRIVER HANDLE	2018-02-12
HWB THEKEN COMPANIES, LLC	EXTRACTOR	2018-02-12
HWA THEKEN COMPANIES, LLC	IMPACTOR	2018-02-12
HTZ THEKEN COMPANIES, LLC	PLANAR	2018-02-12
HTW THEKEN COMPANIES, LLC	DRILL	2018-02-12
HTR THEKEN COMPANIES, LLC	RASP	2018-02-12
HTQ THEKEN COMPANIES, LLC	BROACH	2018-02-12
HTO THEKEN COMPANIES, LLC	REAMER	2018-02-12
HTJ THEKEN COMPANIES, LLC	DEPTH GAUGE	2018-02-09
HTD THEKEN COMPANIES, LLC	FORCEPS	2018-02-09
GFI THEKEN COMPANIES, LLC	OSTEOTOME	2018-02-09
GAD THEKEN COMPANIES, LLC	RETRACTOR	2018-02-09
FZY THEKEN COMPANIES, LLC	HAMMER	2018-02-09
FZX THEKEN COMPANIES, LLC	DRILL GUIDE	2018-02-09
FSM THEKEN COMPANIES, LLC	Sterilization Tray	2018-02-09
PMN K172501 Theken Companies, LLC	INSitu Total Hip System	2017-09-21
PMN K161184 | OQI THEKEN COMPANIES, LLC	iNSitu Total Hip System	2016-11-09
PMN K161184 | OQG THEKEN COMPANIES, LLC	iNSitu Total Hip System	2016-11-09
PMN K161184 | LZO THEKEN COMPANIES, LLC	iNSitu Total Hip System	2016-11-09
PMN K161184 | LPH THEKEN COMPANIES, LLC	iNSitu Total Hip System	2016-11-09
PMN K161184 Theken Companies, LLC	INSitu Total Hip System	2016-10-14