Cleared Traditional

TOTAL TOE SYSTEM II

K941650 · Biomet, Inc. · Orthopedic
Dec 1994
Decision
258d
Days
—
Risk

About This 510(k) Submission

K941650 is an FDA 510(k) clearance for the TOTAL TOE SYSTEM II, a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 19, 1994, 258 days after receiving the submission on April 5, 1994. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K941650 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1994
Decision Date December 19, 1994
Days to Decision 258 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

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

Similar Devices — LZJ Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained

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