510(k) K954186

SLED UNICOMPARTMENT KNEE SYSTEM by Link America, Inc. — Product Code HSX

K954186 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "SLED UNICOMPARTMENT KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Link America, Inc. has at least 10 other 510(k) clearances on record.