510(k) K093046

ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES by Synvasive Technology, Inc. — Product Code ONN

K093046 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES". The FDA issued a decision of Substantially Equivalent on March 22, 2011. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.