Cleared Traditional

THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

K102549 · Ascension Orthopedics, Inc. · Orthopedic
Dec 2010
Decision
105d
Days
—
Risk

About This 510(k) Submission

K102549 is an FDA 510(k) clearance for the THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY, a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on December 21, 2010, 105 days after receiving the submission on September 7, 2010. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K102549 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2010
Decision Date December 21, 2010
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZJ — Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Device Class —

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