510(k) K191297

iNSitu Bipolar Hip System by Theken Companies, LLC — Product Code KWY

K191297 is an FDA 510(k) premarket notification submitted by Theken Companies, LLC for the device "iNSitu Bipolar Hip System". The FDA issued a decision of Substantially Equivalent on September 17, 2019. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Theken Companies, LLC has at least 4 other 510(k) clearances on record.