510(k) K771218

INTRA-ARTICULAR SHAVER by Dyonics, Inc. — Product Code KIJ

K771218 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "INTRA-ARTICULAR SHAVER". The FDA issued a decision of Substantially Equivalent on February 1, 1978. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Dyonics, Inc. has at least 10 other 510(k) clearances on record.