510(k) K042606

MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE by Synthes (Usa) — Product Code GAQ

K042606 is an FDA 510(k) premarket notification submitted by Synthes (Usa) for the device "MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE". The FDA issued a decision of Substantially Equivalent on May 27, 2005. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Synthes (Usa) has at least 10 other 510(k) clearances on record.