Medical Device Manufacturer · US , Akron , OH

Theken Companies, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2016

Recent clearances: iNSitu Bipolar Hip System, iNSitu Total Hip System, iNSitu Total Hip System

View 4 510(k) Devices ↓
4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Theken Companies, LLC Orthopedic ✕

4 devices
1-4 of 4
Cleared Sep 17, 2019
iNSitu Bipolar Hip System
K191297 · KWY
Orthopedic · 126d
Cleared Aug 30, 2019
iNSitu Total Hip System
K192071 · LPH
Orthopedic · 28d
Cleared Sep 21, 2017
iNSitu Total Hip System
K172501 · LPH
Orthopedic · 34d
Cleared Oct 14, 2016
iNSitu Total Hip System
K161184 · LPH
Orthopedic · 170d
Filters
Filter by Specialty
All4 Orthopedic 4