Cleared Traditional

GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)

K950864 · Acu Med, Inc. · Orthopedic
Jul 1995
Decision
154d
Days
—
Risk

About This 510(k) Submission

K950864 is an FDA 510(k) clearance for the GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING), a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 31, 1995, 154 days after receiving the submission on February 27, 1995. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K950864 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1995
Decision Date July 31, 1995
Days to Decision 154 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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