Cleared Traditional

MICRO DYNAMIC MESH

K983528 · Howmedica Corp. · Dental
Dec 1998
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K983528 is an FDA 510(k) clearance for the MICRO DYNAMIC MESH, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on December 23, 1998, 76 days after receiving the submission on October 8, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K983528 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1998
Decision Date December 23, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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