510(k) K981516

STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB by Sterngold/Implamed — Product Code DZE

K981516 is an FDA 510(k) premarket notification submitted by Sterngold/Implamed for the device "STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB". The FDA issued a decision of Substantially Equivalent on May 11, 1998. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterngold/Implamed has at least 10 other 510(k) clearances on record.