Cleared Traditional

K920446 - TOTAL TOE SYSTEM (FDA 510(k) Clearance)

K920446 · Biomet, Inc. · Orthopedic device

Mar 1993

Decision

412d

Days

—

Risk

K920446 is an FDA 510(k) clearance for the TOTAL TOE SYSTEM. This device is classified as a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 22, 1993, 412 days after receiving the submission on February 4, 1992.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K920446 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 04, 1992
Decision Date	March 22, 1993
Days to Decision	412 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	—