510(k) K151347

MIS Spine Frame Instrument Case by Thompson Surgical Instruments — Product Code KCT

K151347 is an FDA 510(k) premarket notification submitted by Thompson Surgical Instruments for the device "MIS Spine Frame Instrument Case". The FDA issued a decision of Substantially Equivalent on October 16, 2015. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Thompson Surgical Instruments has at least 2 other 510(k) clearances on record.