FDA.reportPublic FDA data

THEKEN COMPANIES, LLC

Matched from indexed company URL: Theken Companies, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30024988923002498892THEKEN COMPANIES, LLC1N2026-01-011800 Triplett Blvd Akron OH US 44306

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2008362031210468K241875TheRay Collared and Collarless Femoral StemMEH2024-09-13
2008361217329738K220336Mg-PSZ Ceramic Femoral HeadLPH2022-09-30
2008361873753123K192071iNSitu Total Hip SystemLPH2019-08-30
2008361027321198K191936iNSitu Total Hip SystemLPH2019-08-20
2008361817652726K191297iNSitu Bipolar Hip SystemKWY2019-09-17
2008361848051449K172501iNSitu Total Hip SystemLPH2017-09-21
2008361403044879K161184iNSitu Total Hip SystemLPH2016-10-14
2008361001885329
2008361019292607
2008361124061752
2008361141968670
2008361286343908
2008361356129515
2008361399364870
2008361432827622
2008361445384243
2008361586708485
2008361592775684
2008361669712680
2008361720537947
2008361841017568
2008361851182971
2008361853852687
2008361885630061
2008362028723983
2008362031887028

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LPH52022-09-30
MEH12024-09-13
KWY12019-09-17

PMN#