Cleared Traditional

ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES

K093046 · Synvasive Technology, Inc. · Orthopedic

Mar 2011

Decision

538d

Days

Class 2

Risk

About This 510(k) Submission

K093046 is an FDA 510(k) clearance for the ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES, a Intraoperative Orthopedic Joint Assessment Aid (Class II — Special Controls, product code ONN), submitted by Synvasive Technology, Inc. (Naples, US). The FDA issued a Cleared decision on March 22, 2011, 538 days after receiving the submission on September 30, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K093046 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2009
Decision Date	March 22, 2011
Days to Decision	538 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ONN — Intraoperative Orthopedic Joint Assessment Aid
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Measurement And Interpretation Of Orthopedic Joint Information.