510(k) K955599

STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE by Stryker Corp. — Product Code GDY

K955599 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE". The FDA issued a decision of Substantially Equivalent on February 22, 1996. The device falls under product code GDY (Gauze/Sponge, Internal, X-Ray Detectable), a Class I device regulated under 21 CFR 878.4450. Stryker Corp. has at least 10 other 510(k) clearances on record.