Cleared Traditional

OSTEOMED GREAT TOE SYSTEM

K922211 · Osteomed Corp. · Orthopedic
Nov 1993
Decision
546d
Days
—
Risk

About This 510(k) Submission

K922211 is an FDA 510(k) clearance for the OSTEOMED GREAT TOE SYSTEM, a Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained, submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on November 9, 1993, 546 days after receiving the submission on May 12, 1992. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K922211 FDA.gov
FDA Decision Cleared SN
Date Received May 12, 1992
Decision Date November 09, 1993
Days to Decision 546 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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

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