510(k) K180807

Celling Aspiration Needle by Spine Smith Holdings, LLC — Product Code KNW

K180807 is an FDA 510(k) premarket notification submitted by Spine Smith Holdings, LLC for the device "Celling Aspiration Needle". The FDA issued a decision of Substantially Equivalent on May 24, 2018. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Spine Smith Holdings, LLC has at least 2 other 510(k) clearances on record.