Cleared Traditional

K832740 - FEMORAL FRACTURE ORTHOSIS (FDA 510(k) Clearance)

K832740 · Orthomedics · Orthopedic device
Sep 1983
Decision
36d
Days
—
Risk

K832740 is an FDA 510(k) clearance for the FEMORAL FRACTURE ORTHOSIS..

Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983, 36 days after receiving the submission on August 15, 1983.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number K832740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1983
Decision Date September 20, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code —
Device Class —