510(k) K102885

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX by Stryker Corp. — Product Code JEC

K102885 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX". The FDA issued a decision of Substantially Equivalent on January 14, 2011. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Stryker Corp. has at least 10 other 510(k) clearances on record.