Cleared Traditional

SALTO TALARIS TOTAL ANKLE PROSTHESIS

K060544 · Tornier · Orthopedic

Nov 2006

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K060544 is an FDA 510(k) clearance for the SALTO TALARIS TOTAL ANKLE PROSTHESIS, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Tornier (St. Ismier, FR). The FDA issued a Cleared decision on November 13, 2006, 257 days after receiving the submission on March 1, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K060544 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2006
Decision Date	November 13, 2006
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110