Cleared Traditional

KINETIK GREAT TOE SYSTEM

K924724 · Kinetikos Medical, Inc. · Orthopedic
Jan 1994
Decision
471d
Days
—
Risk

About This 510(k) Submission

K924724 is an FDA 510(k) clearance for the KINETIK GREAT TOE SYSTEM, a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Kinetikos Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on January 5, 1994, 471 days after receiving the submission on September 21, 1992. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K924724 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1992
Decision Date January 05, 1994
Days to Decision 471 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 —

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