Cleared Traditional

HOFFMANN II MIAMI POST

K983419 · Howmedica Corp. · Orthopedic
Nov 1998
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K983419 is an FDA 510(k) clearance for the HOFFMANN II MIAMI POST, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 25, 1998, 57 days after receiving the submission on September 29, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K983419 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1998
Decision Date November 25, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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