510(k) K861822

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI by Valley Forge Scientific Corp. — Product Code GWO

K861822 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI". The FDA issued a decision of Substantially Equivalent on July 11, 1986. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.